Volume 2, No.5, July to September' 2013 - amam-ayurveda.org

Volume 2, No.5, July to September’ 2013 

President’s Message 

Index 

Contents 

Page 

From the Editor’s desk 2 

• AMAM Management Committee 

• Editorial Board 

Ayurveda is not only a treatment way rather it is a universal way to 

keep the entire universe healthy and pleasant. There is a need to educate 

people about Ayurveda, its principles and its practical applications, 

seasonal ailments, changing life style and associated disease, diet etc. 

Ayurveda educates people to maintain and follow the healthy way to 

remain free from diseases. 

Ayurveda have travelled a long way through the history and have 

been guiding the mankind with its valuable resources for treatment & 

prevention of diseases and healthy living. With the recent regulations for 

CTRI registration of clinical trials, registration of the Ethics Committee 

at DCGI and introduction of the guiding tool for Good Clinical Practices 

for ASU medicines, the drug development for ASU medicines will 

become more authentic and scientific. However, there is a need to 

introduce the Ayurvedic concepts like rogi pariksha, prakiti pariksha etc 

while evaluating patients and accordingly the use of anupana, dosage 

regime etc during the treatment. There is always a need to understand 

the difference between the different body constitutions and accordingly 

the treatment. Medicine should be patient-specific and season-specific. 

Therefore, the studies must be based on the Ayurvedic principles and 

planning should be done keeping in consideration of various factors like 

objective, type of patients, indications, treatment modalities and their 

correlation with the practical aspects. With this we can really make a 

robust design and able to justify the ancient claims/believes. 

Best Wishes!! 

Vaidya Devender Triguna 

Honored with Padma Shri and Padma Bhushan 

Regulatory Update 3 

• Registration of Clinical Trials on 

ASU Medicines at Clinical Trials 

Registry-India (CTRI) 

• Registration of Ethics Committee 

• Good Clinical Practice Guidelines for 

Clinical Trials in Ayurveda, Siddha 

and Unani Medicine (GCP-ASU) 

Pharamacopoeial Standards 6 

• Asvagandhadyarista (API) 

• Asvagandha (API) 

• Pictures on Ashwagandha (ICMR) 

• Asvagandhadyarista (AFI) 

Review Article 9 

• Brief review on Ashwagandha 

(Withania somnifera) with special 

reference to its Quality, Efficacy & 

Safety 

Clinical Study 13 

• Double Blind Randomized Placebo 

Controlled Clinical Study on 

Ashwagandha in Chronic Fatigue 

Syndrome

From the Editor’s desk 

Dear Members, 

We have come up with new edition of infoAyurveda for this session 

covering few interesting regulatory updates, Pharmacopeial standards 

of Ashwagandhadyarishta with special mention of Ashwagandha, a 

brief compilation on quality, efficacy & safety of Ashwagandha and 

a brief of clinical study on Stresscom (Ashwagandha capsules) in 

Chronic Fatigue Syndrome. 

As the regulations for getting manufacturing license are getting 

stringent day by day, the implications are imposed for the proof of 

efficacy and safety for the products whether ASU or Proprietary. 

Therefore, in order to apply for the license, the clinical trials now days 

for the ASU medicines are coming in shape. In making the stringency, 

AYUSH Department has made it mandatory to register at Clinical Trial 

Registry of India all the clinical trials that are being conducted in India 

on ASU medicines. This, in turn, will help us to know the number of 

clinical trials initiated in the country alongwith the various indications 

on ASU medicines. Recently, CDSCO has also made it mandatory for 

the registration of the Ethics Committee before giving approval for 

any clinical trial. As per our assumptons this implies that though ASU 

medicines do not fall under perview of DCGI but, without saying, 

for getting the approval from Ethics Committee, the same needs to be 

registered under DCGI. Moreover, the AYUSH department has issued 

guidelines for Good Clinical Practices for the clinical trials in Ayurveda, 

Siddha and Unani Medicine (GCP-ASU). These guidelines are intended 

to serve as a reference source for research scientists, registered medical 

practitioners, manufacturers, and health authorities. These guidelines 

are formulated based on CDSCO Document on GCP Guidelines (2001) 

for Clinical Trials on Pharmaceutical Products. However, at present 

these guidelines are a guiding tool and are for voluntary use by the 

researcher, but will be superseded by regulatory provisions as and when 

brought in. 

In view of the current scenario, developing an ASU medicine, downthe-line 

would require more scientific and methodological approach 

which will have time and financial implications in the drug development 

process on ASU medicines. 

Though all these new regulations/guidelines are welcome steps, 

however, we are of the view that AYUSH industry (especially the small 

scale industries) as on date may not be well equipped to follow all the 

regulations all together; Rather it would have been smooth, in case, if it 

these guidelines/regulations were introduced in a stepwise manner. 

Warm Regards 

Editorial Board 

Patron 

Suresh Sharma 

Pradip Burman 

President 

AMAM’S 

Management Committee 

Vaidya Devender Triguna 

Tel: 011-24354141 

Vice President 

Mr. Ajay Sharma 

Shri Baidyanath Ayurved Bhawan Ltd., 

Asad Mueed 

Hamdard (WAKF) Laboratories 

e-mail:amueed@hamdardindia.com 

Devendra Garg 

Dabur India Limited 

e-mail: gargd@dabur.com 

Dr. Rangesh 

The Himalaya Drug Co. 

e-mail: dr.rangesh@himalayahealthcare.com 

Hon. Gen. Secretary 

Pradeep Multani 

Multani Pharmaceuticals Ltd. 

e-mail: chairman@multaniayurved.org 

Treasurer 

Tejinder Singh 


e-mail: singht@dabur.com 

Jt. Secretary 

Dr. Manju Rakesh 

Sanat Products Limited 

e-mail: ceo@sanat.co.in 

Arun Chauhan 

BACFO Pharmaceuticals (India ) Ltd. 

e-mail: chauhanarun@akcgroup.com 

Dr. N. B. Brindavanam 


e-mail: baba@dabur.com 

M.J. Saxena 

Sanat Laboratories Ltd. 

e-mail: mjsaxena@sanatproducts.co.in 

Members 

Mr. Krishan Chutani 


e-mail: chutanikk@dabur.com 

Dr. Anantha Narayana D B 

Ph.D., Consultant 

e-mail: dba.narayana@gmail.com 

Pramod Sharma 

Shri Baidyanath Ayurved Bhawan Ltd. 

e-mail: pramodsharma54@yahoo.com 

Amit Agarwal 

Natural Remedies 

e-mail: amit@naturalremedies.com 

Vijay Grover 

Kamal Pharmacy, New Delhi 

e-mail: Vijay@kamalpharmacy.com 

Editorial Board 

Chief Editor: 

Mr. Pradeep Multani 

Honorary General Secretary AMAM 

Chairman Multani Pharmaceutical Limited 

H-36, Connaught Place, New Delhi- 1 

Editor: 

Dr. J.L.N. Sastry 

Dabur India Limited, Plot No. 22, Site IV, 

Sahibabad - 201010, Ghaziabad (U.P.) 

Mr. Asad Mueed, Director 

Hamdard (WAKF) Laboratories, Asaf Ali Road, New Delhi – 2 

Mr. Ajay Sharma, President 

Shri Baidyanath Ayurved Bhawan, Naini, 

28, Ishwar Nagar East, New Delhi – 65 

A Publication of: 

Association of Manufacturers of Ayurvedic Medicines 

Regd. Office: 22, Site –IV, Sahibabad, 

Ghaziabad - 201010 (UP), Tel: 0120 4378400, Fax: 0120 4376909 

Correspondence Address: H-36, Connaught Place, New Delhi-110001, 

Tel: 011-23350062, Fax: 011-23350063 

e-mail : amamindia@gmail.com website: www.amam-ayurveda.org 

Disclaimer: Articles in the newsletter are written by independent individuals. News Clips of Upcoming 

Events, Govt. Notifications, Schemes have been taken from different sources. Their opinions do not 

necessarily reflect those of infoAyurveda. They are put here for interest and reference only. None of 

the contributors, sponsors, administrators, or anyone else connected with infoAyurveda in any way 

whatsoever shall be responsible for the appearance of any inaccurate information or for your use of the 

information contained in the newsletter. 

info Ayurveda, Volume 2, No.5, July - Sept’ 2013 

2

Regulatory Update 

REGISTRATION OF CLINICAL TRIALS 

ON ASU MEDICINES AT 

CLINICAL TRIALS REGISTRY-INDIA (CTRI) 

K. 11022/10/2007-DCC (AYUSH) 

Government of India 

Ministry of Health and Family Welfare 

Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and 

Homeopathy (AYUSH) 

IRCS Building, New Delhi 

Date: 22nd August, 2012 

ORDER 

Department of AYUSH takes cognizance of the fact that a large number of clinical trials are conducted in India on AYUSH 

remedies and therapies. These trials involve human participants for proving the efficacy of drugs and therapies used in the AYUSH 

systems. The intention of these trials is to promote evidence based clinical practice for the benefit of patients. Unfortunately, the 

data and other relevant details of clinical trials conducted by the different institutions are difficult to find or many of the trials 

are abandoned or not published due to negative or equivocal results. The practice of evidencebased medicine requires access 

to all information generated through clinical trials. 

Clinical Trial Registry - India (CTRI) has been hosted at the National Institute of Medical Statistics under Indian Council 

of Medical Research. It is a free and online public record system for registration of clinical trials conducted in India. The 

researchers involved in clinical trials including those conducted in AYUSH systems are expected to register the clinical 

trials in CTRI before enrolment of the first patient for the study. The guidelines in this regard are given in the CTRI website 

(www.ctri.nic.in) or can be sought from - 

Administrator, Clinical Trials Registry -India (CTRI) 

National Institute of Medical Statistics, 

(Indian Council of Medical Research). 

Ansari Nagar, New Delhi - 110 029 -India 

Telephone: 91-11 - 26588725, 91-11-26588803 

Fax: 91-11-26589635 

e-mai1: ctr.nims@gmail.com 

All Institutions including Research Councils and National Institutes of AYUSH are hereby directed to ensure registration of 

all AYUSH clinical trials in the clinical trial registry. It is also desired that the registration of clinical trials in the registry be 

informed to the Department of AYUSH annually. 

Anil Kumar Ganeriwala 

Joint Secretary to Govt. of India 


3

REGISTRATION OF ETHICS COMMITTEE 

Regulations for conducting clinical trials in the country are prescribed under Rule 122DA, 122DAA, 122DAB, 122DAC, 

122DD,122E and Schedule Y to the Drugs & Cosmetics Rules, 1945. The Drugs & Cosmetics Rules have been amended vide 

GSR no. 72 (E) dated 08-02-2013 inserting a Rule 122DD, in Schedule ‘Y’ along with other amendments. The amendment 

specifies the detail procedures for the registration of Ethics Committee. 

As per Rule 122DD, No Ethics Committee shall review and accord its approval to a clinical trial protocol without prior 

registration with DCG(I). An application for registration of Ethics Committee shall be made to the DCG(I) in accordance with 

the requirements as specified in the Appendix VIII of Schedule Y. 

In order to streamline the submission of application for registration of Ethics Committee and their examination as per Rule 

122DD, it has been decided to introduce a system of preliminary scrutiny of such applications at the time of their receipt, to 

determine their acceptability for examination by CDSCO. During the preliminary examination, the CDSCO officer(s) will 

scrutinize the application to ensure that it contains all the required administrative as well as technical information in proper 

manner as per the checklist provided. If the applications are not submitted in accordance with the format and the checklist, it 

will not be accepted by CDSCO for further examination. 

Once an application is accepted, the information in the application will be reviewed by CDSCO as per the specified 

procedures. 

i. The Ethics Committee is requested to prepare the application for submission to CDSCO as per appendix-VIII of 

Schedule-Y of D&C Rules and the checklist alongwith undertaking by the committee as per the suggested format. 

ii. 

iii. 

iv. 

The application must be submitted with indexing and page number. Without indexing or page number, no application 

will be accepted. 

Clear and unequivocal information should be provided in the application. 

Text and tables should be prepared using margins that allow the document to be printed clearly without losing any 

information and the left-hand margin should be sufficiently large so that information is not obscured by the method 

of binding. The documents printed on both sides of a page, can be submitted provided, however, one should take 

care that the information is not obscured when the page is placed in a binder. 

v. While submitting reply to a query, the applicant should always enclose with the reply, a copy of query letter issued 

by CDSCO. 

vi. 

All items mentioned in the checklist may not be applicable. The items not relevant to a particular application should 

be marked with “Not Applicable (NA)”. 

This system of preliminary scrutiny is to determine the acceptability of the application for registration of ethics committee 

have come into effect from 25.02.2013. CDSCO has now started giving the registration number w.e.f. 1st April 2013, and the 

information is being regularly updated on its website. 

(For more details, visit CDSCO website www.cdsco.nic.in) 

Ancient Wisdom 

A person should refrain from all those things that take 

him towards fallacy, misery, ignorance and degradation. 

Everybody should work hard to achieve success, growth and prosperity. 

But, this can be possible only when our health is good. 

Atharva Veda 

Atharva Veda 


4

GOOD CLINICAL PRACTICE GUIDELINES FOR 

CLINICAL TRIALS IN AYURVEDA, SIDDHA AND UNANI MEDICINE 

(GCP-ASU) 

Department of AYUSH 

www.indianmedicine.nic.in 

March 2013 

Ministry of Health & Family Welfare 

Government of India, New Delhi 

The department of AYUSH is planning to introduce a regulation for clinical trials for Ayurveda, Siddha and Unani Medicine 

and have issued Good Clinical Practices (GCP) guidelines document for clinical trials in Ayurveda, Siddha and Unani 

(ASU) medicines which will facilitate the researchers and institutions in adopting a standard way of good clinical practice 

while conducting the ASU clinical trials. The guidelines at present are a guiding tool and for voluntary use and reference 

and do not bear any connotation of legal binding, but will be superseded by regulatory provisions as and when brought in. 

Good Clinical Practice is a set of guidelines which encompasses the design, conduct, termination, audit, analysis, reporting 

and documentation of the studies involving human subjects. 

The objective of the document is to encourage that clinical studies in ASU systems are undertaken in accordance with ethical 

and scientific standards and safety aspects and rights of participants are protected. Adhering to methodical documentation 

of trials will help bringing credibility to the efforts of persons and institutions involved in the process, which otherwise was 

lacking for want of any ASU-specific guiding document. The guidelines are significant as although the ASU systems are 

known for their long history of safe and effective use, yet validation of safety and efficacy using scientific and evidencebased 

methodologies is needed for the purpose of universal acceptability, gaining confidence of practitioners and satisfaction 

of end users in the products. The guidelines seek to establish two cardinal principles: protection of the rights of human 

subjects and authenticity of ASU medicine clinical trial data generated. 

This guideline is based on CDSCO Document on GCP Guidelines (2001) for Clinical trials on Pharmaceutical products and 

covers the major headings as follows: 

i. Protocol - Relevant components of Protocol, General Information, Objectives and Justification, Ethical Considerations, 

Study design, Inclusion, Exclusion & Withdrawal of Subjects, Handling of the Product(s), Assessment of Efficacy 

and Safety, Statistics, Finance and Insurance, Publication policy etc 

ii. Ethical & Safety Considerations - Ethical Principles, Ethics Committee & its responsibilities, Composition, Review 

Procedures , Submission of Application, Record Keeping etc 

iii. Informed Consent Process - Informed Consent of Subject, Essential information, Research subjects, Confidentiality, 

Compensation for participation or injury, Pregnant or nursing women, Children, Vulnerable groups etc 

iv. Responsibilities of Sponsor - Investigator and Institution Selection, Contract, SOP, Allocation of duties and 

responsibilities, Study management, Data handling and Record keeping, Compensation for participation, Information 

on Investigational Products, Supply, Storage and handling of ASU drug/Patent or Proprietary Medicines, Safety 

Information, Adverse Drug Reaction Reporting, Study Reports, Monitoring, Audit etc 

v. Responsibilities of Investigator - Qualifications, Medical care of the study subjects, Monitoring and Auditing of 

records, Communication with Ethic Committee, Compliance with the protocol etc 

vi. Responsibilities of Monitor 

vii. Record Keeping & Data Handling - Documentation, Corrections, Electronic Data Processing, Validation 

viii. Role of Biostatistician - Study Design, Randomization and Blinding, Statistical Analysis etc 

ix. Clinical Trials of Contraceptives, Therapies/Surgical Procedures/Medical devices. 

x. Appendix - Guidelines for Evaluation of Ayurveda, Siddha and Unani Medicine, Ethical Issues (Ethical Guidelines 

for Biomedical Research Human Participants, Indian Council of Medical Research 2006, Investigator’s Brochure, 

Essential Documents) 

(For more details on the guideline visit the website of AYUSH www.indianmedicine.nic.in) 


5

Pharmacopoeial Standards for Ayurvedic Formulations 

and Raw Materials 

DEFINITION 

ASVAGANDHADYARISTA 

(API, PART – II, VOL –II) 

Asvagandhadyarista is fermented liquid preparation made with the 

ingredients in the Formulation composition given below. It contains not 

more than 10 per cent, and not less than 5 per cent of alcohol that is self 

generated in the preparation over a period of time. 

FORMULATION COMPOSITION 

1 Asvagandha API Withania somnifera Rt. 2.4 kg 

2 Musali API Chlorophytum tuberosum Rt. 960 g 

3 Manjistha API Rubia cordifolia Rt. 480 g 

4 Haritaki API Terminalia chebula P. 480 g 

5 Haridra API Curcuma longa Rz. 480 g 

6 Daruharidra API Berberis aristata St. 480 g 

7 Madhuka (Yasti API) Glycyrrhiza glabra Rt. 480 g 

8 Rasna API Pluchea lanceolata Rt./Lf.* 480 g 

9 Vidari API Pueraria tuberosa Rt. Tr. 480 g 

10 Partha (Arjuna API) Terminalia arjuna St. Bk. 480 g 

11 Mustaka (Musta API) Cyperus rotundus Rz. 480 g 

12 Trivrt (API) Ipomoea turpethum Rt. 480 g 

13 Ananta (Sveta sariva API) Hemidesmus indicus Rt. 384 g 

14 Syama (Krsna sariva API) Cryptolepis buchanani Rt. 384 g 

15 Sveta candana API Santalum album Ht. Wd. 384 g 

16 Rakta candana API Pterocarpus santalinus Ht. Wd. 384 g 

17 Vaca API Acorus calamus Rz. 384 g 

18 Citraka API Plumbago zeylanica Rt. 384 g 

19 

Jala API for decotion 

reduced to 

Praksepa dravyas 

Water 


98.304 l 

12.2881 

20 Maksika (Madhu API) Honey 14.4 

21 Dhataki API Woodfordia fruticosa Fl. 768 g 

22 Sunthi API Zingiber officinale Rz. 96 g 

23 Marica API Piper nigrum Fr. 96 g 

24 Pippali API Piper longum Fr. 96 g 

25 Tvak API Cinnamomum zeylanicum St. Bk. 192 g 

26 Ela (Suksmaila API) Elettaria cardamomum Sd. 192 g 

27 Patra (Tejapatra API) Cinnamomum tamala Lf. 192 g 

28 Priyangu API Callicarpa macrophylla Fl. 192 g 

29 Nagakesara API Mesua ferrea Stmn. 96 g 

*Actual part used in the formulation 

METHOD OF PREPARATION 

Take the raw materials of pharmacopoeial quality. 

Wash, dry and powder the ingredients numbered 1 to 18 (Kvatha dravya) 

of the formulation composition individually and pass through the sieve 

number 44 to obtain coarse powder. 

Clean, dry and powder the ingredients numbered 22 to 29 (Praksepa 

dravya) of the formulation composition individually and pass through the 

sieve number 85 to obtain fine powder. 

Add specified amounts of water to the Kvatha dravya, soak overnight, 

heat, reduce to one eighth and filter through muslin cloth to obtain Kvatha. 

Allow to cool. 

Transfer the filtrate to clean container; add ingredient numbered 20, 21, of 

the formulation composition. Finally add the finely powdered Praksepa 

dravyas and seal the mouth of the container. 

Shift the container to the fermentation room and constantly check for the 

signs of completion of fermentation process. 

Filter the fermented material through a clean muslin cloth. 

Pack in air tight containers and allow for maturation. 

DESCRIPTION 

Clear, dark brown liquid without frothing and significant sedimentation; 

with astringent taste 

IDENTIFICATION 

Thin Layer Chromatography: 

Dry 50 ml of the formulation in vacuum to remove the self generated 

alcohol. Add 50 ml water to dissolve the extract and partition successively 

with n-hexane (50 ml x3) and chloroform (50 ml x 3). Filter and concentrate 

the chloroform extract under vacuum and weigh. Dissolve 20 mg of 

residue in ml of chloroform and carry out the thin layer chromatography. 

Apply separately 10 µl of solution prepared as above an 5 µl of standard 

solution of withanolide D prepared by dissolving 1 mg in 1 ml of methanol, 

on TLC plate and develop the plate to a distance of 8 cm using toluene: 

ethyle acetate: acetic acid (5:4:1) as mobile phase. After development, 

allow the plate to dry in air and spray with anisaldehyde-sulphuric acid 

reagent followed by heating at 105º for about 10 minutes and examine 

under ultraviolet light (366 nm). It shows major spots at R f 0.27 (dark 

purple), 0.44 (purple, corresponding to withanolide D), 0.61 (light grey), 

and 0.70 (dark brown). 

PHYSICO-CHEMICAL PARAMETERS 

Total phenolic content: 

Total solids: 

Specific gravity (at 2500): 1.05 to 1.20 

pH: 3.50 to 4.50 

Reducing sugars: 

Non-reducing sugars: 

Alcohol content: 

Methanol: 

0.104 to 0.260 per cent w/v equivalent to 

tannic acid 

Not less than 18.5 per cent w/v 

Not less than 13 per cent w/v 

Not more than 0.70 per cent w/v 

5 to 10 per cent v/v 

Absent 

Other requirements: Microbial limit: & Aflatoxins: 

(As per Appendix mention in API) 

6

STORAGE 

Store in a cool place in tightly closed amber coloured bottle, protect from 

light and moisture. 

THERAPEUTIC USES 

Murccha (syncope), Apasmara (epilepsy), Sosa (cachexia), Unmada 

(mania/psychosis), Karsya (emaciation), Arsa (piles), Agnimandya 

(digestive impairment), Vataroga (neurological disorders). 

DOSE 

15-30 ml orally with equal amount of water after meals twice a day. 

ASVAGANDHA 

(API, PART – I, VOL – I ) 

Asvagandha consists of dried mature roots of Withania somnifera Dunal. 

(Fam. Solanaceae); a perennial shrub, found in waste land, cultivated filed 

and open ground throughout India; widely cultivated in certain areas of 

Madhya Pradesh and Rajasthan; roots collected in winter, washed and cut 

into short pieces 

SYNONYMS 

Sansk : Hayagandha, Vajigandha 

Assam : Ashvagandha 

Beng. : Ashvagandha 

Guj. : Asgandha 

Hindi : Asgandh 

Kan. : Angarberu, Hiremaddina-gida 

Kash. : Asagandh 

Mal. : Amukkuram 

Mar. : Asagandha, Askagandha 

Ori. : Aswagandha 

Punj. : Asgandh 

Tam. : Amukkaramkizangu 

Tel. : Pennerugadda 

Urdu : Asgand 

DESCRIPTION 

(a) 

Macroscopic – Roots straight, unbranched, thickness varying with 

age, roots bear fiber-like secondary roots, outer surface buff to greyyellow 

with longitudinal wrinkles; crown consists of 2-6 remains of stem 

base; variously thickened; nodes prominent only on the side from where 

petiole arises, cylindrical, green with longitudinal wrinkles; fracture, short 

and uneven, Odour, characteristic; taste, bitter and acrid. 

IDENTITY, PURITY AND STRENGTH 

Foreign matter Not more than 2%, 

Total ash Not more than 7%, 

Acid-insoluble ash Not more than 1%, 

Alcohol (25%) soluble extractive Not less than 15%, 

(As per Appendix mention in API) 

ASSAY 

Aswagandha consists of not less than 0.2 per cent of total alkaloids, when 

assayed as follows:- 

Take about 30g accurately weighed of the powdered drug, cover with 

Alcohol (90 per cent) and allow to stand overnight. Extract for 6 hours 

so wet apparatus and concentrate to syrup residue. Treat with 25, 20, 15 

and 10 ml portions of 5 per cent Sulphuric Acid until complete extraction 

of alkaloid is affected. 

To the combined acid extract add an excess of Dragandorf’s reagent. 

Filter under suction and dissolve the residue in Acetone, Shake the acetone 

solution with freshly prepared suspension of 2g Silver Carbonate in 10 

ml of Water. Filter the solution and wash the precipitate with Acetone, 

Alcohol and water in that order. Pass sufficient Hydrogen Sulphide 

through the filtrate. Boil the solution for 10 minutes, filter and evaporate 

under vacuum in a tared flask. Add to the residue 5 ml of Ethyl Alcohol, 

evaporate to dryness, repeat the process once again and weight the residue 

to constant weight in vacuum dessicator. 

CONSTITUENTS 

Alkaloids and withanolides. 

PROPERTIES AND ACTION 

Rasa : Tikta, Kasaya 

Guna : Laghu 

Virya : Usna 

Vipaka : Madhura 

Karma : Vatakaphapaha, Balya, Rasayana, Vajikarana 

IMPORTANT FORMULATIONS 

Asvagandhadyarista, Asvagandhadi leha, Balasvagandha laksadi taila. 

THERAPEUTIC USES 

Ksaya, Daurbalya, Vataroga, Sotha, Klaibya. 

DOSE 

3-6g of the drug in powder form 

(b) Microscopic – Transverse section of root shows cork exfoliated 

or crushed; when present isodiamatric and non-lignified; cork cambium 

of 2-4 diffused rows of cells; secondary cortex about twenty layers of 

compact parenchymatous cells; phloem consists of sieve tubes, companion 

cells, phloem parenchyma; cambium 4-5 rows of tangentially elongated 

cells; secondary xylem hard forming a closed vascular ring separated by 

multiseriate medullary rays; a few xylem parenchyma. 

Picture 1: Ashwagandha Fruiting Twig 


7

Picture 2: Ashwagandha Fresh Root 

Picture 3: Ashwagandha Dried Roots 

Picture 1, 2 & 3: Courtesy Quality Standards of Indian Medicinal Plants, ICMR, 2011 

ASVAGANDHADYARISTA 

(Bhaisajyaratnavali, Murcchadhikara; 13-17) 

rqykn~/kZa pk”oxU/kk;k eqlY;k% iyfoa”kfrA 

eqft’Bk;k gjhrD;k jtU;kseZ/kqdL; pAA3AA 

jkLukfonkjhikFkkZuka eqLrd f=o`rksjfiA 

Hkkxku~ n”kiyku~ n|knuUrk”;ke;ksLrFkk AA4AA 

pUnuf}r;L;kfi opkk;kf”przdL; pA 

Hkkxku’Viyku~ {kq..kkez’Vnzks.ks·EHkl% ipsr~AA5AA 

nzks.k”ks’ks d’kk;s·fLeu~ iwrs “khrs iznki;srA 

/kkrD;k% ‘kksM”kkiya ekf{kdL; rqykrz;e~AA6AA 

C;ks’ka rq f}iya frztkrdprq%iye~A 

prq% iya fiz;axks”p f}iya ukxds”kje~AA7AA 

¼HkS’kT;jRukoyh] ewPNkZf/kdkj% 13&17½ 

(AFI, PART –I, II Edition) 

24 Pippali (Fr.) 96 g 

25 Tvak (St. Bk.) 192 g 

26 Ela (Suksmaila) (Sd.) 192 g 

27 Patra (Tejapatra) (Lf.) 192 g 

28 Priyangu (Fl.) 192 g 

29 Nagakesara (Stmn.) 96 g 

DOSAGE 

12 to 24 ml. 

IMPORTANT THERAPEUTIC USES 

Murccha, Apasmara, Sosa, Unmada, Karsya, Arsa, Agnimandya, Vataroga. 

1 Asvagandha (Rt.) 2.400 kg 

2 Musali (Rt.) 960 g 

3 Manjistha (Rt.) 480 g 

4 Haritaki (P.) 480 g 

5 Haridra (Rz.) 480 g 

6 Daruharidra (St.) 480 g 

7 Madhuka (Yasti ) (Rt.) 480 g 

8 Rasna (Rt./Lf.) 480 g 

9 Vidari (Rt. Tr.) 480 g 

10 Partha (Arjuna) (St.Bk.) 480 g 

11 Mustaka (Musta) (Rz.) 480 g 

12 Trivrt (Rt.) 480 g 

13 Ananta (Sveta sariva) (Rt.) 384 g 

14 Syama (Krsna sariva (Rt.) 384 g 

15 Sveta candana (Ht. Wd.) 384 g 

16 Rakta candana (Ht. Wd.) 384 g 

17 Vaca (Rz.) 384 g 

18 Citraka (Rt.) 384 g 

19 Water for decoction 98.304 l 

reduced to 

12.288 l 

Praksepa dravyas 

20 Maksika (madhu) 14.400kg 

21 Dhataki (Fl.) 768 g 

22 Sunthi (Rz.) 96 g 

23 Marica (Fr.) 96 g 

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8

BRIEF REVIEW ON ASHWAGANDHA (Withania somnifera L. Dunal) 

With special reference to its quality, efficacy and safety 

Satyajyoti Kanjilal, Arun Gupta, Sanjay Sharma and JLN Sastry 

Dabur Research & Development Center, 

Sahibabad, Ghaziabad, U.P. 

1. INTRODUCTION ON ASHWAGANDHA - PLANT 

DESCRIPTION, DISTRIBUTION & CULTIVATION 1 

2. QUALITY SPECIFICATIONS OF 

ASHWAGANDHA 

Withania somnifera commonly known as Ashwagandha, is a dicotyledonous 

plant belonging to the family Solanaceae. The plant of Ashwagandha 

is usually erect, branched, unarmed, shrubby, upto 1.25 m in height, 

minutely stellate tomentose especially on the stem, leaf veins and the 

calyx. Leaves are simple, petiolate and upto 10 cm long. Flowers shortly 

pedicullate, 4-6 mm in diameter. Berry globose, enclosed in the green 

persistent calyx, 5 mm in diameter, green when unripe, orange-red when 

mature, containing numerous small, smooth, discoid seeds. The roots of 

the commercial varieties of Ashwagandha cultivated in Madhya Pradesh 

are soft textured, tuberous starchy, unbranched or slightly branching in 

lower half with slightly fusiform crown, very light, pale brown colour and 

smooth thin pale brown Bark. 1 

It is a shrubby bush which grows in dry arid soils of subtropical regions. 

In India, the plant grows well throughout the drier parts and in the sub 

tropical and semi temperate regions, including the states of Maharashtra, 

Madhya Pradesh, Gujarat, Rajasthan, Uttar Pradesh, Haryana and Punjab 

extending to Himachal Pradesh and Jammu and Kashmir from plains to 

the height of 1700 meters. Plant seldom occurs in the north eastern part 

covering Orissa, Bengal, Sikkim and Assam. 1 

The estimated annual production of Ashwagandha roots in India is 

about few thousand tonnes. The plant is cultivated mainly in the northwestern 

region of Madhya Pradesh and adjoining villages of Kota district 

of Rajasthan. Ashwagandha is planted late in the rainy season around 

August-September and harvested in the next May. The semi-tropical areas 

receiving 500-700 mm rainfall are suitable for cultivation of this rainfed 

crop. It requires dry season during its growing period; 1-2 late winter 

rains are conducive for the proper development of roots. It grows well 

in sandy loam or light red soil, having pH 7.5-8.0, with good drainage. 

Seed germination normally takes 6-7 days after sowing. The plant starts 

flowering and bearing fruits from February-March onwards. The crop 

is ready to harvest in April-May i.e. 240-250 days after sowing. The 

maturity of crop is judged by drying out of leaves and red berries. The 

entire plant is uprooted for roots which are separated from the aerial part 

by cutting the stem 1-2 cm above the crown. The roots are then either cut 

transversely into small pieces (7-10 cm) or dried as a whole in the sun. 

Berries are hand plucked separately, dried, beaten and seeds are taken 

out. 1 Ashwagandha has been reported to be infected by fungi, viruses, 

phytoplasmas, nematodes and pests. Roots collected in winter, washed 

and cut into short pieces. 2 

Quality specification of Ashwagandha has been published in various 

Pharmacopeias, two of them are referred below - 

i. Ayurvedic Pharmacopoeia of India 3 

According to Ayurvedic Pharmacopoeia of India the following different 

parameters are measured for the standardization of Ashwagandha like 

Foreign matter (Not more than 2 per cent), Total Ash (Not more than 7 per 

cent), Acid-insoluble ash (Not more than 1 per cent), Alcohol (25 per cent) 

soluble extractive (Not less than 15 per cent) etc 

ii. Indian Pharmacopoeia 4 

According to the Indian Pharmacopoeia of India 2007, Ashwagandha 

contains not less than 0.02 per cent of total withanolide A and withaferin 

A, calculated on the dried basis. 

Description: Buff to grayish – yellow roots. Taste, slightly mucilaginous, 

bitter and acrid. 

Identification: 

a. Macroscopic – Primary roots are slight, conical or finger like in 

shape, variable in thickness with the age. Secondary roots are thin 

and fibrous. Surface buff to grayish – yellow with longitudinal 

wrinkles. 

b. Microscopic – Vessels with bordered pits and horizontal perforations. 

Fibres aseptate with pointed ends. Wood elements lignified. Starch 

grains abundant, simple, mostly spherical, reniform – oval with 

central hilum. Microcrystal in parenchyma cells. 

c. Thin Layer Chromatography – 

Mobile phase: A mixture of 9 volumes of chloroform and 1 volume 

of methanol. 

Test solution: Reflux 3 g of coarsely powdered substance under 

examination with 50 ml methanol for 15 minutes, cool and filter. 

Reference Solution: Reflux 0.6 g of coarsely powdered ashwagandha RS 

with 10 ml methanol for 15 minutes, cool and filter. Apply to the plate 10 

µl of each solution as bands 10 mm by 2 mm. Allow the mobile phase to 

rise 8 cm above the line of application. Dry the plate in air, spray with 

solution of anisaldehyde reagent. Heat at 100 o for 5-10 minutes and 

examine the plate in day light. The chromatographic profile of the test 

solution is similar to that of the reference solution. 


9

Tests 

a. Foreign organic matter: Not more than 2.0 per cent. 

b. Ethanol – soluble extractive: Not less than 10.0 per cent 

c. Water – soluble extractive: Not less than 15 per cent 

d. Ash: Not more than 7.0 per cent 

e. Acid – insoluble ash: Not more than 1.2 per cent 

f. Heavy metals: 1.0 g. 

g. Loss on drying: Not more than 12.0 per cent, determined on 5 g by 

drying in an oven at 105° 

h. Microbial contamination: Complies with the microbial contamination 

tests. 

i. Assay: Ashwagandha contains not less than 0.02 per cent of total 

withanolide A and withaferin A, calculated on the dried basis. 

3. EFFICACY & SAFETY OF ASHWAGANDHA 

i. History and Uses 

The drugs derived from the plant kingdom have been used to alleviate 

or cure human diseases since ages. Ashwagandha is one such traditional 

ancient plant whose roots have been employed as a valuable drug in 

Indian traditional systems of medicine Ayurveda, Siddha and Unani. 

Ashwagandha is given the name ‘Indian Ginseng’ mainly because of its 

aphrodisiac and restorative properties. 1 

Ashwagandha (Withania somnifera) is well known for its medicinal 

properties since the time of Puranvasu Atreya, an ancient scholar who 

taught medicine at Taxila university about 1000 BC and mentioned 

numerous medicinal uses of Ashwagandha. Ayurvedic Texts including 

Charak Samhita, Sushrut Samhita and Astang Hridaya and Bhav- 

Prakasha mention Ashwagandha to be general tonic as well as a cure of 

morbidity arising from diseases such as pain, arthritis and inflammation. 

Ashwagandha has been described as one of the components of the Balya 

(Tonics), Brimhaneeya (Weight promoting drugs) and Madhurskandha by 

Charaka (Su. 4/2.7; V. 8/139). Ancient authentic Ayurvedic Text books like 

Kaiyadeva Nighantu and Madanpal Nighantu have referred Ashwagandha 

for its properties and uses. It was used in many tonic preparations as 

prescribed by Chakradutta and others and was a major constituent of 

aphrodisiac formulations. Ashwagandha mixed with honey and butter was 

recommended for sexual debility. The plant was first mentioned in the 

English language texts by Van Rheede who called it ‘Pevetti’. 1 

The uses and properties of the roots of Ashwagandha (Withania somnifera) 

are mentioned in various texts. In the Pharmacopoeia of India, the root 

of Ashwagandha are used in rheumatism and dyspepsia. 1 The roots are 

astringent, bitter, thermogenic, stimulant, aphrodisiac, diuretic and tonic. 

They are useful in leucoderma, constipation, insomnia, lumbar pain, 

nervous disorders, asthma, cardiac disorders, ulcers, carbuncles, scabies, 

marasmus of children, senile debility. 2 It is mainly indicated in the 

treatment of Sosha (Malnutrition), Sukra dosa (Defects of Semen), Vata 

vyadhi (Nervine Diseases), Unmada (Mental Diseases) and Apasmara 

(Epilepsy). 1 

ii. Folk Lore Uses of Ashwagandha 1 

In the foot hills of western Himalaya region, the root powder of Withania 

somnifera is used in pulmonary tuberculosis. The root paste is used in the 


treatment of glandular swelling of bubonic plague. In Madhya Pradesh, 

the drug (root) is used for toning up uterus of women who habitually 

miscarry. The berries and seeds are given in chest complaints. 

The parts of Ashwagandha are heated and applied to painful joints and 

boils by the Meo community of Gurgaon district in Haryana. The tribal 

people of Eastern Rajasthan use Ashwagandha for treatment of lumbago, 

rheumatism and asthma. 

In Mysore district the crushed berries along with the juice of castor plant 

are drunk in cases for relieving the poison of serpent. 

In Tibet, powder of the roots is used as general tonic in seminal diseases 

as a nervine tonic. 

iii. Reference available in published Ayurvedic 

literature about Ashwagandha 

• Charak Samhita, Sutrasthanam 5 

Ashwagandha has been referred as one of the bulk promoters. 

• Charak Samhita, Vimanasthanam 5 

Ashwagandha is refered in Madhurskandha (Sweet Group) and a 

preparation of it with milk is described in various disorders. 

• Bhavprakash Nighantu, Guduchyadi Varga 6 

Ashwagandha is referred as Balkarak (Strength Promoter), 

Sukravardhak (Increases Semen), Rasayana (Rejuvenating agent), 

Sotha (Inflammation) and Ksaya nashak (Anti –Tubercular). 

• The Ayurvedic Pharmacopoeia of India 2 

Ashwagandha is described to have actions as Balya (Strength 

Promoter), Rasayana (Rejuvenating agent), Vajikarana (Aphrodisiac). 

It is having therapeutic uses in Ksaya (Tuberculosis), Daurbalya 

(Weakness), Vataroga (Neurological Disease), Sotha (Inflammation) 

and Klaibya (Male Impotence) 

• Kaiyadeva Nighantu 7 

Ashwagandha is described as Sukra vardhak (Increases Semen), 

Bala karak (Strength Promoter), Rasayana (Rejuvenating agent, 

Pushtikarak (Provides nourishment). The therapeutic uses in Ksaya 

(Tuberculosis), 

Kasa (Cough), Vrana (Ulcer), Sopha (Oedema), 

Kandu (Itching), Vish (Poison), Krimi (Helminthiasis/Worm 

infestation), Swasa (Dyspnoea/Asthma) and Ksata (Wound). 

• Madanpal Nighantu 8 

iv. 

Ashwagandha is used in treating Sotha (Inflammation), Kshaya 

(Tuberculosis) and acts as Strength Promoter and Rasayana 

(Rejuvenating agent). 

Concurrent use of Ashwagandha 

Ashwagandha (Withania somnifera) is used in varied number of formulation 

in Ayurveda, both in Patent & Proprietary and other textual medicines. The 

herb has been widely used in a diverse number of conditions for hundreds 

of years, in India. It is evident from the below mentioned formulations 

indicated in different health conditions – 

• Drakshadi Prayogati 9 

Ashwagandha has been mentioned as an ingredient of a formulation 

stated as strength promoting and indicated in general weakness, 

10

urinary stones and hemorrhagic diseases. 

• Mahasarasvati Churnam 10 

Used as main ingredient in the formulation indicated as a memory 

enhancer. 

• Masatailam (Brhat) 11 

One of the ingredients of the formulation indicated for the treatment 

of paralytic conditions. 

• Bhujangi Gutika 12 

The formulation containing Ashwagandha has been mentioned in this 

text. It is indicated for the treatment of all types of nervous afflictions 

(Vatavyadhi) 

• The Ayurvedic Formulary of India 13 

AFI, published by Government of India, Ministry of Health and Family 

welfare, Department of Indian Systems of Medicine & Homoeopathy, 

New Delhi has indexed many formulations containing Ashwagandha 

as one of the ingredient. Few formulations among those as mentioned 

in the AFI part I and II are given below in table 1 - 

Table 1: Different formulation in which Ashwagandha is used alongwith its usage 

S.No 

Preparation / 

Formulation 

Percentage of 

Ashwagandha 

(Approx) 

Dosage 

Form 

Use 

1 Asvagandhadyarista 1.93% 

Liquid 

Syncope (Murccha), Epilepsy (Apasmara), Cachexia (Sosa), Digestive impairement 

(Agnimandya), Neurological Disorder (Vatavyadhi) 

2 Balarista 6.45% Liquid 

Digestive impairement (Agnimandya), Weakness (Daurbalya), Neurological 

Disorder (Vatajroga), Cachexia (Karshya) 

3 Asvagandhadi Lehya 5.53 % Paste 

4 Guducyadi Modaka 1.07% Tablet 

5 

6 

Maha Rasnadi Kvatha 

Churna 

Trayodasanga 

Guggulu 

Cachexia (Krsatva), Disorders of Blood (Raktavikara), Rejuvinator (Rasayana), 

Balya (Strength Promoter), Vajikarana (Aphrodisiac) 

Dysuria (Mutrakrichha), Mutraghata (Urinary Obstruction), Pthisis (Ksaya), 

Bleeding disorders (Raktapitta) 

1.33% Powder Rheumatism, Tremors, Diseases of female genital tract 

7.14% Pills 

Katigraha, Grdhrasi, Hanugraha, Asthivata, Hrtgraha, Yanidosa, Asthibhagna, 

Khanja vata 

7 Dadhika Ghrta 1.13% Ghee 

8 Phala Ghrta 1.20% Ghee 

9 Prameha Mihira Taila 1.26% Oil 

Epilepsy (Apasmara), Mania /Psychosis (Unmada), Vata roga, Udara roga, 

Grahani, Anaha, Arsa 

Diseases of Children (Bala roga), Specific Disorders of Children (Bala graham), 

Disorders of semen (Sukra vikara), Disorder of female genital tract (Yoni 

vikara), Infertility (Vandhyatva), Disease during pregnancy (Garbhini roga), 

Emaciation (Karsya) 

Neurological Diseases (Vata vyadhi), Intermittent Fever (visama Jvara), Urinary 

Disorder (Prameha), Dhvajabhanga, Burning sensation (Daha), Thirst (Pipasa), 

Emesis (Chardi), Dryness of mouth (Mukha sosa) 

10 Balaguduchyadi tail 0.95% Oil Gout (Vataraktaa) 

11 

Masabaladi Kvatha 

curna 

14.28% Powder 

Paralysis/Hemiplegia (Paksaghata), Neck Rigidity (Manyastambha), Tinnitus 

(Karnanada), Ear ache (Karnaruja) 

12 

Brhat Asvagandha 

Ghrta 

55.84% Ghee 

Oligospermia (Ksinasukra), Loss of muscle mass (Hinamamsa), Infertility 

(Vandhyatva), Cataract (Timira), Neurological Disorder (Vatavyadhi), Pthsis 

(Ksaya), Cough (Kasa), Asthma (Svasa), Hiccup ( Hikka), Intermittent Fever 

(Visama Jvara), 

13 Sarasvata Curna 8.33% Powder Epilepsy (Apasmara), Mania/Psychosis (Unmada) 

14 Ashvagandha Taila 53.09% Oil 

15 Mahalaksadi Taila 2.31% Oil 

Neurological Disorder (Vataroga), Bleeding Disorder (Raktapitta), Menorrhagia/ 

Metrorrhagia or both (Asrgdara), Disorder of Female Genital Tract (Yonivikara), 

Mamsa Ksaya (Emaciation of Muscle) 

Fever (Jvara), Intermittent Fever (Visama Jvara),Cough (Kasa), Asthma (Svasa), 

Coryza (Pratisaya), Itching (Kandu), Lower Backache (Katisula) 

16 Asvagandhadi Churna 21.77% Powder Tridosaksaya 


11

• Marketed Preparations/Formulations 14 

Preparations/Formulations made of Ashwagandha are being marketed in 

India by various companies in various indications like anti-depressant, 

anxiolytic, general health tonic, memory booster, central nervous system 

stimulant, sedative and tranquilizer, immunomodulator etc under different 

brand names since many years. There is no specific safely concerns yet 

reported/documented on the formulations. 

V. Pharmacological Studies on Ashwagandha 

Scientifically, Withania somnifera has been widely studied for its beneficial 

effects. The extracts have been tested in various pharmacological 

parameters. A study has shown that Withania somnifera extract 

significantly reduced the fibro-sarcoma onset as well as incidence at the 

end of therapy. There was a significant reduction in the tumor volume with 

Withania somnifera extract treated mice as compared to the control and 

it significantly increased the survival rate. 15 In another study the markers 

of chronic stress, namely, augmented gastric ulceration, and perturbed 

adrenocortical activity were attenuated by Withania somnifera which 

indicated that Withania somnifera has significant adaptogenic activity. 16 

Withania somnifera tend to normalize the stress-induced neurochemical 

perturbations. It has shown to be effective in attenuation chronic stress 

induced physiological and behavioral disturbances, was also effective 

in tending to normalize chronic stress induced neurochemical changes. 17 

Withania somnifera exerts cardioprotective effect in the experimental 

model of isoprenaline-induced myonecrosis in rats. Augmentation of 

endogenous antioxidants, maintenance of the myocardial antioxidant 

status and significant restoration of most of the altered haemodynamic 

parameters may contribute to its cardioprotective effect. 18 The root 

powder of Withania somnifera with the presence of natural antioxidants, 

bioflavanoids, and other bioactive compounds scavenged the free radicals 

generated by gentamycin and ameliorated the severity of gentamycininduced 

nephrotoxicity by enhancing the antioxidant system and protecting 

the cellular integrity of kidney and liver tissues. 19 Administration of an 

extract from the powdered root of the plant Withania somnifera was found 

to stimulate immunological activity in mice. Treatment with doses of 

Withania root extract was found to enhance the total WBC count. Bone 

marrow cellularity as well as α-esterase positive cell number also increased 

significantly after the administration of Withania extract. Treatment with 

Withania extract along with the antigen produced an enhancement in the 

circulating antibody titre and the number of plaque forming cells in the 

spleen. Withania extract inhibited delayed type hypersentivity reaction in 

mice and have shown an enhancement in phagocytic activity of peritoneal 

macrophages when compared to control. 20 

4. POSOLOGY 

• In Powder Form (Ashwagandha Churna): 3-6 g in powder form 2 

• Ashwagandha Ghrita: 2-3 drops in children 21 

• Kwath (Decoction): 90-100 ml in Adults 22 

5. SUMMARY AND CONCLUSION 

The present review was compiled to establish the safety aspect of 

Ashwagandha (Withania somnifera) through the background of its 

history, usage (folklore, Ayurvedic literature, concurrent use), efficacy 


and quality standards in view of the Indian context. Various published 

litratures, review articles, pharmacopoeias, formularies are being refered 

to compile this brief on Ashwagandha. There are many formulations in 

which Ashwagandha is used however, in this review we have refered few 

among them. 

Ashwagandha finds its reference as a time tested age old herb and is 

described in various Ayurvedic literature for its actions and therapeutic 

uses and has been used since the era dating back to 1000 B.C. safely to cure 

human diseases. Ayurvedic literature and published books are available 

documenting its properties and uses either as prescribed medicine or as 

folk / traditional medicine both in external and internal route. Its properties 

and therapeutic uses are also described in the scheduled Ayurvedic books 

of Government of India. 

Ashwagandha (Withania somnifera) has been tested in various quality 

parameters for standardization in different pharmacopoeias and 

fingerprinting (TLC & HPLC) techniques. In the reviewed Pharmacopoeias 

i.e the Ayurvedic Pharmacopoeia of India and Indian Pharmacopoeia, the 

standardization techniques have been described and complete assay along 

with other parameters are mentioned. 

Scientific studies and the historical references in the Ayurvedic literatures, 

concurrent usage, popularity of the plant, historical safe usage both as 

medicine and health promoter agent, establishes its safety and efficacy. 

6. REFERENCES 

1. Withania somnifera – The Indian Ginseng Ashwagandha by Sandhya Singh and Sushil 

Kumar published by Central Institute of Medicinal and Aromatic Plants (CIMAP), 

Lucknow, India. 

2. Database on medicinal plants used in Ayurveda, Vol 3, pp 88-93, Published by Central 

Council for Research in Ayurveda and Siddha, New Delhi. 

3. The Ayurvedic Pharmacopoeia of India, Part 1, Volume – 1, Government of India, 

Ministry of Health and Family Welfare, Department of Indian System of Medicine and 

Homoeopathy, New Delhi. 

4. Indian Pharmacopoeia of India, 2007 

5. Charak Samhita, Sutrasthana, Chapter IV and Vimanasthanam, Chapter VIII, Sloka 139, 

Chikitsa Sthanam Published by Chaukhamba Orientalia. 

6. Bhavprakash Nighantu by Sri brahmasankara Misra and Ruplalji Vaisya published by 

Chaukhamba Sanskrit Sansthan, Page 393 -394. 

7. Kaiyadeva Nighantu by Prof. Priyavrata Sharma & Dr Guru Prasad Sharma, Published by 

Chaukhamba Orientalia, Varanasi, Sloka 1044-1046 

8. Madanpal Nighantu by Khemraj Srikrishna Das Prakashan, Mumbai, Sloka 73-74 

9. Bharat Bhaishajya Ratnakar, Translated by Gopinath gupta –Vol III –B, Jain Publishers, 

New Delhi, Edn. 2 nd , Reprint Aug 1999, PP-36. 

10. Bharat Bhaishajya Ratnakar, Translated by Gopinath gupta –Vol IV –B, Jain Publishers, 


11. Bharat Bhaishajya Ratnakar, Translated by Gopinath gupta –Vol IV –B, Jain Publishers, 


12. Bharat Bhaishajya Ratnakar, Translated by Gopinath gupta –Vol III –B, Jain Publishers, 

New Delhi, Edn. 2nd, Reprint Aug 1999, PP-634. 

13. The Ayurvedic Formulary of India Part I and II: Published by Government of India, 

Ministry of Health and Family welfare, Department of Indian Systems of Medicine & 

Homoeopathy, New Delhi 

14. Ayurvedline – Ayurvedic Drug Index. 

15. Anti-tumor and Anti-oxidant activity of Withania somnifera in Swiss albino mice 

conducted by Dr S K Gupta, All India Institute of Medical Sciences, Ansari Nagar, New 

Delhi. 

16. Adaptogenic properties of Aswagandha (Withania somnifera) by Prof S K Bhattacharya, 

Varanasi and Prof. D. Bhattacharya, Calcutta 

17. Neurochemical studies on Withania somnifera conducted by Dr S K Bhattacharya, 

Department of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, 

Varanasi. 

18. Basic Clin Pharmacol Toxicol. 2004 Apr;94(4):184-90; Mechanisms of cardioprotective 

effect of Withania somnifera in experimentally induced myocardial infarction; Mohanty I, 

Arya DS, Dinda A, Talwar KK, Joshi S, Gupta SK 

19. J Basic Clin Physiol Pharmacol. 2010;21(1):61-78; Protective effect of Withania 

somnifera root powder on lipid peroxidation and antioxidant status in gentamicin-induced 

nephrotoxic rats; Jeyanthi T, Subramanian P 

20. J. Ethnophamacology 71 (200) 193-200; Immunomodulatory activity of Withania 

somnifera; L. Davis & G. Kutton 

21. Ashwagandha Ghrita, Bhaisajya Ratnavali, Balrogadhikara, P-735 

22. Sharangdhara Samhita, Edition PHC Murry, Chaukhamba Publisher 2001, P- 111 

12

Double Blind Randomized Placebo Controlled Clinical Study on 

Ashwagandha in Chronic Fatigue Syndrome 

INVESTIGATORS 

Dr. G. G. Mansharamani, Dr. B. M. Makkar, 

Dr. Rachel Koreth, Dr. Gautam Dutta and 

Dr. A. Mukherjee 

REPORT YEAR: September 1996 

1. INTRODUCTION 

Chronic Fatigue Syndrome (CFS) is a chronic disorder of unknown 

etiology, characterized by persistent lack of drive and energy to carry out 

day to day activities and concentrate on work. The fatigue may worsen 

with physical or mental activity, but doesn’t improve with rest. There 

is no specific laboratory test and clear criteria to identify homogeneous 

(sub) groups in patients presenting with unexplained fatigue, and to assess 

clinical status and disability in patients of Chronic Fatigue Syndrome. 

Number of remedies have been tried out with variable results; Work-up 

and therapy have to be based on this integrated approach. 

Ashwagandha (Withania somnifera) known for its beneficial effects in 

humans may help for combating stress in the patients with Chronic Fatigue 

Syndrome. Therefore, the study on Stresscom Capsule (Ashwagandha 

Capsule) was conducted to evaluate the efficacy and safety in patients 

suffering from Chronic Fatigue Syndrome. 

parameters of this study. It was studied by two methods. In the first method, 

the patient’s fatigue level was measured on a scale of 0-3, where 0 being 

no fatigue and 3 being the maximum fatigue. On the second method, the 

number patients achieving a reduction in various level score at the end of 

the study was counted and were compared. 

Routine investigations e.g. Urine analysis, Chest X-ray PA, Serum 

Electrolytes and Alkaline Phosphatase, and other blood parameters were 

done before and after the trial. 

Decoding was done at the end of the study, Batch B as ‘Stresscom’, and 

Batch A was ‘Placebo’. 

3. OBSERVATIONS AND RESULTS 

A total of 86 patients completed the study, with 39 in Placebo and 47 

in Stresscom group. There were 18 males and 21 females in Placebo 

group. Stresscom group had 26 males and 21 females. The drugs were 

administered at a dose of 2 capsules at breakfast and dinner given for 8 

to 12 weeks. 

All patients were followed up at 4 week intervals for 8 to 12 weeks, along 

with medical check-up and investigations. A careful watch was kept for 

side effects, if any. 

2. MATERIALS AND METHODS 

Patients of Chronic Fatigue Syndrome reporting to the Medical OPD of 

LNJP Hospital, New Delhi were selected for the study after a thorough 

physical examination. The patients were explained the purpose of the 

study and their written informed consent was obtained. 

Patients enrolled in the study were randomly divided into two batches A 

and B, matched for age, sex, and disease profile. Stresscom and Placebo 

were supplied as identical looking capsules coded A or B. The identity of 

the code was sealed till the end of the study. 

3.1. PHYSICAL EXAMINATION 

There was no significant difference found in general physical examination 

between both the groups. 

3.2. KARNOFSKY PERFORMANCE INDEX (KPI) 

Both Stresscom and Placebo groups have shown improvement in the scores 

of Karnofsky Performance Scale Index (KPI) in each visit compared to 

the baseline, however, no significant difference was found on between the 

group analysis (Fig 1). 

Figure 1: Karnofsky Performance Scale Index in different visits 

Patients with malignancy, autoimmune diseases, tuberculosis, lyme 

disease, infectious diseases, AIDS/HIV infection, psychiatric chronic 

diseases diagnosed or suggested by history, inflammatory chronic diseases 

or chronic hepatitis, neuromuscular diseases like multiple sclerosis 

or myasthenia gravis, endocrine diseases like DM, thyroid hypo- or 

hyperactivity, adrenal hypo- or hyperactivity, drug dependency, cardiac 

disease, GI, hepatic, renal or hematological disease etc were excluded 

from the study. 

Score 

90 

85 

80 

75 

70 

Basal 

4th Week 

8th Week 

12th Week 

The physical examination like heart rate, blood pressure, respiratory rates, 

body temperature and body weight was done before and after the study. 

65 

Placebo 

Stresscom 

The patient’s performance was evaluated on Karnofsky Performance Scale 

Index. This Scale helps in classification of patients as per their functional 

impairment. The index can be used to compare effectiveness of different 

therapies and to assess the prognosis in individual patients. The lower the 

Karnofsky score, the worse the survival for most serious illnesses. 

The control over the level of fatigue was one of the most important 


3.3. FATIGUE LEVEL 

3.3.1 Control over the level of fatigue – The mean initial fatigue level 

was 2.4 ±0.6 and 2.5±0.5 in Placebo and Stresscom group respectively, 

which was reduced to 2.1±0.6 and 1.7±0.6 after the study respectively 

(Fig 2). The difference was significant. 

13

Figure 2: Control over Fatigue in both the group 

Table 1: Parameters assessed before and after 8 weeks of therapy in both 

the group 

Fatigue Scale 

3 

2.5 

2 

1.5 

1 

0.5 

0 

Basal 

Final 

Placebo 

Stresscom 

Placebo 

Stresscom 

Parameters 

n Before After n Before After 

Remarks 

Headache 9 1.3±0.5 0.8±0.6 12 1.8±0.4 0.5±0.5 A

3.6. TOLERANCE 

The drug was well tolerated in both the groups with no patient requiring 

withdrawal from therapy. In Placebo group, 3 patients had minor self 

limiting adverse effects in the form of nausea, vomiting and anorexia; 

36 of 39 (92%) patients tolerated the placebo without any specfic safety 

concerns. In Stresscom group, 6 patients had side effects in the form of 

minor self limiting nausea in 3, heart burn in 1, belching with epigastric 

fullness in 1 and menorrhagia in 1 patient that was easily controlled with 

symptomatic therapy; 41 of 47 patients (87%) tolerated Stresscom without 

any specfic safety concerns. The two batches did not differ significantly 

in tolerance. 

4. SUMMARY AND CONCLUSIONS 

The double blind randomized placebo controlled study was conducted 

in 86 patients of Chronic Fatigue Syndrome attending the Out Patient 

Department of LNJP Hospital, New Delhi, for a period of 8 to 12 weeks. 

The following points can be concluded basis the result of the clinical 

study: 

• Stresscom had shown improvement on multiple parameters of 

psychosomatic complaints of Chronic Fatigue Syndrome like fatigue, 

headache, muscle pain, weakness, joint pains, feverish feeling, sleep 

abnormality, neuropsychiatric complaints, forgetfulness, irritability, 

confusion, lack of concentration as compared to the baseline scores 

and that of placebo. A statistical significant improvement was noted in 

parameters of fatigue, headache, muscle pain and weakness compared 

to placebo. 

• Stresscom had shown improvement in the scores of Karnofsky 

Performance Scale Index (KPI) in each visit compared to the baseline, 

however, no significant difference was found on between the group 

analysis. 

• Both Stresscom and Placebo were found to be well tolerated during the 

course of study. 

• Stresscom might be useful in relieving symptoms of Chronic Fatigue 

Syndrome. 

5. ACKNOWLEDGEMENT 

Dabur India Limited is thankful to the Investigators for conducting the 

study on the product Ashwagandha Capsule, which is being marketed in 

India by Dabur as Stresscom Capsules 

6. REFERENCES 

• Medicinal Plants of India and Pakistan; Dastur, J.F, D.B . Taraporvala 

& Sons, Bombay; (1970), 3rd edition pp.177. 

• Role of Aswagandha in various types of Arthropathies; Bector, N.P., 

Puri, A.S. & Sharma, D: (1968) Ind. J. Med. Res. 56 (10), pp 1581- 

1583. 

• Dimensional assessment of chronic fatigue syndrome; Jan H.M.M. 

Vercoulen, Caroline M.A. Swanink, Jan F.M. Fennis et.al;Journal of 

Psychosomatic Research; Volume 38, Issue 5, July 1994, Pages 383– 

39 

• Chronic fatigue syndrome (CFS) -A review and a proposition of a biopsycho-social 

model of the chronic fatigue syndrome; Rolf H. Adler; 

Swiss Med Wkly 2004;134:268–276 

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