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<strong>Wishing</strong> <strong>our</strong> <strong>members</strong><br />

a <strong>very</strong> <strong>auspicious</strong> <strong>and</strong> <strong>delightful</strong><br />

<strong>Navratri</strong>, Durga pooja<br />

<strong>and</strong> Dushera<br />

Volume. 2 No.2 Oct. - Dec., 2012<br />

Index<br />

Contents Page<br />

From the Editor’s desk 2<br />

• Editorial Board<br />

• Executive Committee<br />

Regulatory Update 3<br />

• Draft Notification from Department<br />

of AYUSH<br />

News Update 5<br />

• Neem on ASEAN’s negative list<br />

• Efficacy of most herbal drugs need to be<br />

doubted<br />

• Dept of Ayush plans to support effectiveness<br />

studies of 500 select ASU Drugs<br />

Pharamocopial St<strong>and</strong>ards 9<br />

• Marichadi Gutika<br />

• Guda<br />

• Yava<br />

• Yavaksara<br />

Clinical Study 13<br />

• Management of Osteoarthritis


From the Editor’s desk<br />

Dear Members,<br />

Benefits of Neem have been known to all of us since the time<br />

immemorial.<br />

In India, the plant is variously known as “Sacred Tree,” “Heal All,”<br />

“Nature’s Drugstore,” “Village Pharmacy” <strong>and</strong> “Panacea for all<br />

diseases”. Products made from neem trees have been used in <strong>our</strong><br />

country for over two millennia for their medicinal properties<br />

Sanskrit medical writings refer to the usage of neem’s fruits, seeds,<br />

oil, leaves, roots <strong>and</strong> bark for various benefits.<br />

Modern scientific research has also confirmed neem’s curative<br />

benefits in many diseases <strong>and</strong> has provided indications that neem<br />

might be used much more widely in coming future.<br />

Neem is known to be anthelmintic, antifungal, antidiabetic,<br />

antibacterial, antiviral, contraceptive <strong>and</strong> sedative. It is considered<br />

as a major component in Ayurvedic <strong>and</strong> Unani medicine <strong>and</strong> is<br />

particularly prescribed for skin diseases.<br />

Substantial experimental evidence <strong>and</strong> clinical data is today available<br />

in support of the efficacy of neem.<br />

Having known this, it is indeed <strong>very</strong> unfortunate that herbs like neem<br />

are being considered under negative list of plants in the ASEAN<br />

countries.<br />

Recently, a conference was held in Singapore wherein an expert<br />

committee of TMHS intended the inclusion of neem in the ‘ASEAN’s<br />

list of negative ingredients for traditional medicine <strong>and</strong> health<br />

supplement (TMHS)’<br />

The product working group (PWG) discussed this <strong>and</strong> is said to be<br />

finalising the inclusion of Azadirachta indica or neem in the negative<br />

list which may result in unnecessary confusion among the public<br />

regarding such a commonly used <strong>and</strong> time tested medicinal plant.<br />

This could become a serious threat to jeopardize the exports business<br />

of AYUSH Industry.<br />

AMAM, strongly criticizes this inclusion of ‘Azadirachta indica’ or<br />

neem/nimba in the ASEAN list of Negative Ingredients for Traditional<br />

Medicine <strong>and</strong> Health Supplement (TMHS) by the ‘Product Working<br />

Group’ (PWG) which happens to be an expert committee group under<br />

TMHS.<br />

The Association has already requested the requisite intervention of<br />

the department of Ayush <strong>and</strong> Ministry of health on this issue.<br />

By targeting neem, without credible evidence, the report sends a<br />

wrong message to the entire globe involved in trading <strong>and</strong> developing<br />

products based on the traditional science.<br />

We invite view of <strong>our</strong> fellow <strong>members</strong> on the above issue.<br />

Warm Regards,<br />

Dr. Manju Rakesh<br />

On behalf of full editorial board<br />

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

Events, Govt. Notifications, Schemes have been taken from different s<strong>our</strong>ces. Their opinions do not<br />

necessarily reflect those of Info Ayurveda. They are put here for interest <strong>and</strong> reference only. None of the<br />

contributors, sponsors, administrators, or anyone else connected with Info Ayurveda in any way whatsoever<br />

shall be responsible for the appearance of any inaccurate information or for y<strong>our</strong> use of the information<br />

contained in the newsletter.<br />

Members of AMAM’S Management<br />

Committee<br />

Patron<br />

Jt. Secretary<br />

Vaidya Brahaspati Dev Triguna Ajay Sharma<br />

Ashok Ch<strong>and</strong> Burman<br />

Shri Baidyanath Ayurved Bhawan,<br />

Suresh Sharma<br />

Pradip Burman<br />

New Delhi<br />

E-mail: ajdelhi@msn.com<br />

Arun Chauhan<br />

President<br />

BACFO Pharmaceuticals (India) Ltd.<br />

Vaidya Devender Triguna<br />

Tel: 011-24354141<br />

E-mail: chauhanarun@akcgroup.com<br />

Dr. N.B. Brindavanam<br />

Dabur India Limited<br />

Vice President<br />

Anurag Sharma<br />

Shri Baidyanath Ayurved Bhawan<br />

Ltd., (Jhansi)<br />

E-mail: baba@dabur.com<br />

M. J. Saxena<br />

Sanat Laboratories Ltd.<br />

E-mail: mjsaxena@anatproducts.co.in<br />

E-mail: anurag@baidyanathayurved.com<br />

Asad Mueed<br />

Hamdard (WAKF) Laboratories<br />

E-mail: amueed@hamdardindia.com<br />

Devendra Garg<br />

Dabur India Limited<br />

E-mail: gargd@dabur.com<br />

Ravi Prasad<br />

The Himalaya Drug Co.<br />

E-mail: ravi.prasad@himalayahealthcare.com<br />

Members<br />

Vijay Grover<br />

Kamal Pharmacy, New Delhi<br />

E-mail: vijay@kamalpharmacy.com<br />

Pramod Sharma<br />

Shri Baidyanath Ayurved Bhawan<br />

Ltd. Patna<br />

E-mail: pramodsharma54@yahoo.com<br />

Dr. Manju Rakesh<br />

Dabur India Limited<br />

Hon. Gen. Secretary<br />

Pradeep Multani<br />

Multani Pharmaceuticals Ltd.<br />

e-mail: chairman@multaniayurved.org<br />

Treasurer<br />

Tejinder Singh<br />

Dabur India Limited<br />

e-mail: singht@dabur.com<br />

E-mail: rakeshm@dabur.com<br />

Amit Agarwal<br />

Natural Remedies<br />

E-mail: amit@naturalremedies.com<br />

Dr. Anantha Narayana D B,<br />

Ph.D., Consultant<br />

Email: dba.narayana@gmail.com<br />

Editorial Board<br />

Chief Editor:<br />

Mr. Pradeep Multani<br />

Honorary General Secretary AMAM<br />

Chairman Multani Pharmaceutical Limited<br />

36-H Connaught place, New Delhi- 1<br />

Editor:<br />

Dr. Manju Rakesh<br />

Dabur India Limited, Plot No. 22, Site IV,<br />

Sahibabad - 201010, Ghaziabad (U.P.)<br />

Mr. Anurag Sharma, Executive Director<br />

Shri Baidyanath Ayurved Bhawan Pvt. Ltd. (Jhansi)<br />

B- 6/5, Safdarjung Enclave, New Delhi<br />

Mr. Asad Mueed, Director<br />

Hamdard (WAKF) Laboratories, Asaf Ali Road, New Delhi – 2<br />

Mr. Ajay Sharma, President<br />

Shri Baidyanath Ayurved Bhawan, Naini,<br />

28, Ishwar Nagar East, New Delhi – 65<br />

A Publication of:<br />

Association of Manufacturers of Ayurvedic Medicines<br />

Regd. Office: 22, Site –IV, Sahibabad,<br />

Ghaziabad - 201010 (UP), Tel: 0120 4378400, Fax: 0120 4376909<br />

Correspondence Address: H-36, Connaught Place, New Delhi-110001,<br />

Tel: 011-23350062, Fax: 011-23350063<br />

E-mail : amamindia@gmail.com website: www.amam-ayurveda.org<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 2


D ear Readers,<br />

MiNiSTRy of HEAlTH AND fAMily WElfARE<br />

(Department of Ayurveda, Yoga <strong>and</strong> Naturopathy, Unani, Siddha <strong>and</strong> Homeopathy)<br />

NOTIFICATION<br />

New Delhi, the 30th July, 2012<br />

G.S.R. 597(E)- The following draft of certain rules further to amend the Drugs <strong>and</strong> Cosmetics Rules,<br />

1945, which the Central Government proposes to make rules in exercise of the power conferred by<br />

section 33N of the Drugs <strong>and</strong> Consmetics Act. 1940 (23 of 1940), is hereby published as required by the<br />

said section for the information of all persons likely to be affected thereby <strong>and</strong> notice is hereby given<br />

that the said draft rules will be taken into consideration after the expiry of a period of forty five days<br />

from the date on which copies of the Official Gazette in which this notification is published are made<br />

available to public;<br />

Regulatory Update<br />

Dept of AYUSH, Ministry of Health <strong>and</strong> family welfare recently issued a draft notification to amend the D & C Rules, we are reproducing the<br />

same for y<strong>our</strong> kind information <strong>and</strong> perusal. Please read on…..<br />

Objections or suggestions, if any, may be addressed to the Secreatary (Department of Ayurveda, Yoga<br />

<strong>and</strong> Naturopathy, Unani, Sidha annd Homeopathy) (AYUSH) Ministry of health <strong>and</strong> Femily Welfare,<br />

India Red Cross Society Building. New Delhi 110 001;<br />

Any objection or suggestion, which may be received from any person with respect to the said draft rules<br />

within the period specified above, will be taken into consideration by the Central Government.<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 3


DRAFT RULE<br />

1. (1) These rules may be called the Drugs <strong>and</strong> Cosmetic (5th Amendment) Rules, 2012<br />

(2) They shall come into force the date of their final publication in the offical Gazette<br />

2. In the Drugs <strong>and</strong> Cosmetics Rules, 1945, in rule 157 after sub-rule (1A) the following sub-rules shall be<br />

inserted, namely:-<br />

“(1B) No manufacturer shall be allowed to use any prefix or suffix with the Ayurveda Siddha <strong>and</strong> Unani<br />

Medicine defined under clause (a) of section 3 of the Act <strong>and</strong> the rules made thereunder.<br />

(1C) No medicine manufactured under the definition of clause (h) of section 3 of the Act should resemble<br />

or mimic the names of formulations mentioned in the books of First Schedule of the Drugs <strong>and</strong> Cosmetics<br />

Act 1940.”<br />

[No. K. 11020/06/2011-DCC (AYUSH)]<br />

BALA PRASAD, Jt. Secy.<br />

Note: The Principal rules were published in Official Gazette Vide Notification No. 1:28-10j 45-11(1).<br />

dated 21-12-1945 <strong>and</strong> the last amended vide G.S.R. No. 573 (E), dated 17-0-2012<br />

Ancient Wisdom<br />

Knowledge of Sakti leads to salvation. “Sakti-Jnanam Vina Devi Nirvanam Naiva Jayate—O Devi! Without the<br />

knowledge of Sakti, Mukti cannot be attained”—says Siva to Devi. The Jiva or the individual soul thinks, when he is<br />

under the influence of Maya, that he is the doer <strong>and</strong> the enjoyer <strong>and</strong> identifies himself with the body. Through the grace of<br />

Sakti <strong>and</strong> through Sadhana or self-culture, the individual soul frees himself from all fetters <strong>and</strong> attains spiritual insight<br />

<strong>and</strong> merges himself in the Supreme.<br />

Worship of the Divine Mother, intense faith <strong>and</strong> perfect devotion <strong>and</strong> self-surrender, will help you to attain Her grace.<br />

Through Her grace alone you can attain Knowledge of the Imperishable.<br />

Glory to Sri Tripurasundari, the World-Mother, who is also Rajarajesvari <strong>and</strong> Lalita-Devi. May Her blessings be upon<br />

you all. May you all obtain the grace of Sakti, the Universal Mother <strong>and</strong> enjoy the supreme bliss of final emancipation.<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 4


News Update<br />

Neem on ASEAN’s negative list<br />

Praveen Bose / Chennai/ Bangalore Sep 04, 2012<br />

The traditional Indian drug makers are now a worried lot. An innocuous document revealed at a conference<br />

held in Singapore on June 29-30, 2012, threatens to jeopardise the export prospects of the whole Ayurveda<br />

industry.<br />

In a letter to the ministry of health <strong>and</strong> family welfare, the Association of Manufacturers of Ayurvedic Medicines<br />

(AMAM) has expressed its fears over the snowballing of this move. It could affect exports to other<br />

parts of the world, believes AMAM.<br />

Pradeep Multani, honorary general secretary of AMAM, told Business St<strong>and</strong>ard, “The move will affect<br />

Ayurveda, Siddha <strong>and</strong> Unani (ASU) branches of traditional medicines. It could have a devastating effect on<br />

the trade in ASU herbs <strong>and</strong> drugs. With India set to sign the FTA with ASEAN, it could ultimately even affect<br />

the sales of these products in India.” Multani expressed his fears that it could be first of many more herbs that<br />

could be targeted that are used in these traditional systems of medicines.<br />

With India in talks with the ASEAN <strong>members</strong> for a Free Trade Agreement (FTA), Ayurveda was expected to<br />

play a major role in healthcare exports. “The local <strong>and</strong> allopathic drug makers there are probably fearing a<br />

threat,” added Multani. Not all ASEAN countries though are keen to accept Indonesia’s move.<br />

Philipe Haydon, CEO, The Himalaya Drug Company, said, “Many other countries may take a cue from this<br />

<strong>and</strong> restrict imports of these products.” According to Pharmexcil (Pharmaceuticals Export Promotion Council<br />

Of India), set up by Ministry of Commerce & Industry, neem is among the top 25 herbal <strong>and</strong> AYUSH<br />

product to be exported. It generated Rs 33.98 crore in 2009-10, which was double that of the previous year.<br />

Care Kerala estimates that the total market for products containing neem <strong>and</strong> neem extracts is Rs 500 crore.<br />

Dr K G Raveedran, medical director, Coimbatore Arya Vaidya Pharmacy, sees an international conspiracy<br />

behind this, saying there’s an international lobby trying to check the spread of Ayurveda from India. To prove<br />

his point, he says how the US <strong>and</strong> UK have set up their own Ayurveda universities <strong>and</strong> recognise degrees<br />

only from there for doctors wanting to practise Ayurveda there.<br />

“This looks just like an extension of that,” added Dr Raveendran.<br />

Laments Dr Raveendran: “The Indian government does not have experts advising on the subject. We are<br />

always looking for endorsements from the West before accepting a drug. We have asked the Centre to intervene,<br />

but the response has been cold.” He asserts that neem is the most important ingredient in Ayurveda.<br />

According to Mumbai-based NGO Neem Foundation, neem is used to treat rashes, wounds, chicken pox,<br />

ulcers <strong>and</strong> jaundice.<br />

C<strong>our</strong>tesy: Business St<strong>and</strong>ard<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 5


Efficacy of most herbal drugs need to be<br />

doubted as several raw drugs not available<br />

in market<br />

Peethaambaran Kunnathoor, Chennai<br />

Wednesday, July 04, 2012<br />

The claims about the quality of most of the herbal drugs available today, especially in Ayurveda <strong>and</strong><br />

Siddha, are questionable because of non-availability of certain key raw drugs <strong>and</strong> other malpractices<br />

impacting the quality of these ingredients, according to a study conducted by a member of the<br />

Central Council of Indian Medicine (CCIM).<br />

Adulteration <strong>and</strong> substitution of raw materials are the two major factors that lead to the poor quality<br />

of conventional ayurvedic <strong>and</strong> Siddha medicines, said Dr K G Viswanathan, the CCIM member <strong>and</strong><br />

the principal of Vaidyaratnam Ayurveda College in Thrissur in Kerala.<br />

According to him some of the major manufacturing companies have stopped the production of<br />

certain key ayurvedic drugs because of shortage of raw drugs. He said the conventional Ayurveda<br />

medicine for fever “Draakshaadi Kashaayam” is not available today because the main ingredient of<br />

its production, the roots of “Kumizhu” (Gmelina arborea), is not available.<br />

“If the medicine is available anywhere, its quality has to be tested as there is no substitution for its<br />

ingredients, especially for “Kumizhu”. The tree itself is not seen anywhere. So we are suspicious<br />

of the quality of ‘Draakshaadi Kashaayam’ if it is available in any shop. The production of the<br />

Kashaayam was stopped years ago,” he told Pharmabiz in a telephonic conversation.<br />

There are Draakshaadi tablets <strong>and</strong> Arishtams coming to Kerala from other states claiming as drugs<br />

made from the roots of ‘Kumizhu’, but the veracity of those claims is also questionable, he said.<br />

There are more than 60 species of medicinal plants in the list of endangered species <strong>and</strong> government<br />

has banned their collection for commercial production of medicines. Even for samples for the<br />

purpose of study, special permission is required from the forest department. Collection of the plants<br />

‘Kottam’ (Saussurea lappa), used for the manufacture of the popular ‘Kottamchukkaathi Thailam”,<br />

‘Rakthach<strong>and</strong>anam’ (Red s<strong>and</strong>alwood) used for “shaarivadyaasavam” <strong>and</strong> the bark of Ashoka tree<br />

(Sarca indica) used for ‘Ashokaarishtam’ is restrained by laws. “In such a situation, the manufacturing<br />

companies are forced to stop production of these drugs or use substitutions which will impact<br />

the quality of the drugs”, Dr Viswanathan said. He added that several conventional ‘Kashaayams’<br />

are not available now in the market due to the non-availability of raw materials.<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 6


The bark of Ashoka tree is <strong>very</strong> much beneficial for women who suffer from irregular or painful<br />

menstruation. It is also useful in internal bleeding haemorrhoids <strong>and</strong> haemorrhagic dysentery, the<br />

doctor said.<br />

For industry purpose, sufficient quantity of these raw drugs cannot be assured. In his study report,<br />

Dr Viswanathan says that almost all the raw drugs available today seem to be suspicious of their<br />

quality. The manufacturers claim that they bring these rare species of plants from north India, but<br />

the quality of the products has to be questioned as in the local herbal markets in north India more<br />

adulteration <strong>and</strong> substitutions take place. These malpractices may be deliberate or sometimes unintentional,<br />

but it affects the efficiency of the drugs. In place of genuine drugs, substitutions are taking<br />

place where the raw drugs have similar appearance to that of genuine drugs <strong>and</strong> are deliberately<br />

sold in some herbal markets, the CCIM member alleged.<br />

Further, the study shows that, the recent habitat destruction being occurred due to infrastructure<br />

development for urbanization <strong>and</strong> over exploitation by the increasing number of manufacturers,<br />

many of the ‘annual herbs’ <strong>and</strong> bio diversity spots are permanently getting depleted <strong>and</strong> destroyed<br />

at an alarming rate. The road sides <strong>and</strong> village c<strong>our</strong>t yards in Kerala, once up on a time, were rife<br />

with medicinal plants, shrubs <strong>and</strong> annual herbs like “Kurunthotti” (Sida rhombi folia), Chittamruth<br />

(Tinospora cordifolia), Vayalchulli (Hygrophila Auriculata), Keezharnelli (Phyllanthus amarus)<br />

etc. are now permanently getting lost.<br />

The doctor said increase in the use of drugs also cause for shortage of raw drugs. In the year 1990,<br />

Kerala had only 200 manufacturing units, the number has increased to 700 in 2012. Apart from<br />

production of number of medicines, the quantity also has increased. Considering such fast rate of<br />

growth of this segment, measures have to be taken for development of medicinal plants.<br />

The study recommends for cultivation of medicinal plants by hi-tech methods with the help of<br />

agricultural universities. Besides community herbal garden, kitchen garden, medicinal plant board<br />

projects etc. should be enc<strong>our</strong>aged. Coordinated efforts of the departments of Forest, Agriculture<br />

<strong>and</strong> Health must be initiated <strong>and</strong> opportunities for researches in the field should also be given.<br />

Dr Viswanathan said that he would submit his report to the government of Kerala for Vision 2030<br />

<strong>and</strong> also to the Central Medicinal Plant Board.<br />

C<strong>our</strong>tesy: PHARMABIZ.com<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 7


Dept. of Ayush plans to support effectiveness<br />

studies of 500 select ASU drugs for better<br />

global recognition<br />

Joseph Alex<strong>and</strong>er, New Delhi<br />

Monday, July 16, 2012<br />

The Department of Ayush may initiate a scheme to support biological activity <strong>and</strong> effectiveness studies<br />

of 500 select Ayurveda, Siddha <strong>and</strong> Unani (ASU) medicines so that they get a wider acceptance in the<br />

international markets <strong>and</strong> as part of further streamlining the regulations <strong>and</strong> st<strong>and</strong>ards in the sector.<br />

The Steering Committee of the Planning Commission had made recommendations for supporting shelf<br />

life studies, development of phyto-chemical marker compounds, safety studies, biological activity studies<br />

<strong>and</strong> efficacy/effectiveness of 500 ASU drugs. The proposal is being pursued with the Planning Commission<br />

for approval, s<strong>our</strong>ces in the department said.<br />

Other recommendations of the panel included development of new scientific monographs <strong>and</strong> revision<br />

of already published monographs, selection of priority drugs with high market potential by the Pharmacopoeia<br />

Commission of Indian Medicine <strong>and</strong> development of Ayush drug dossiers to facilitate entry of<br />

Ayush drugs in the international market.<br />

Elaborating on the specific achievements of the Department in the last five years in the regulatory areas,<br />

an official of the Department said three national institutes <strong>and</strong> a Pharmacopoeia Commission of Indian<br />

Medicine have been/are being set up.<br />

Publication of pharmacopoeial st<strong>and</strong>ards <strong>and</strong> St<strong>and</strong>ard Operating Procedures (SOPs) of 152 ayurvedic<br />

formulations, publication of pharmacopoeial monographs of 101 single plant drugs <strong>and</strong> 21 minerals,<br />

publication of macro <strong>and</strong> microscopic <strong>and</strong> TLC atlases of 172 drugs, <strong>and</strong> development of eight community<br />

herbal monographs in the format given by European Medicines Evaluation Agency (EMEA) for<br />

submission to European Union were the other highlights of the performance.<br />

The Steering Committee of the Planning Commission also had recommended Rs.50 crore towards the<br />

activities in the regulatory area for the current Five Year Plan. The amount was sought for augmenting<br />

pharmacopoeia work to develop 1000 monographs <strong>and</strong> strengthening Pharmacopoeia Commission <strong>and</strong><br />

associated laboratories to accelerate the work of st<strong>and</strong>ardization <strong>and</strong> quality parameters of ASU drugs<br />

as per global requirements <strong>and</strong> acceptability, to take up development of monographs of such medicinal<br />

plants as are widely used in folklore/tribal medicine but not documented in ASU literature <strong>and</strong> to work<br />

on the lines of other Pharmacopoeia Commissions of the world.<br />

C<strong>our</strong>tesy: PHARMABIZ.com<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 8


Pharmocopial St<strong>and</strong>ards For Ayurvedic Formulations<br />

<strong>and</strong> Raw Materials<br />

efjpa d’kZek= L;kr~ fiIiyh d’kZlfEerk AA93AA<br />

v/kZd’kksZ ;o{kkj% d’kZ;qXea p nkfMee~ A<br />

,rPpw.khZd`ra ;qT;kn’Vd’kZxqMsu fgAA94AA<br />

“kk.kizek.ka xqfVdk d`Rok oD=s fo/kkj;sr~A<br />

vL;k% izHkkokr~ losZ·fi dklk ;kUR;so lM~-{k;e~ AA95AA<br />

¼“kkM~-xZ/kjlafgrk] e/;e[k.M] v/;k; 7] 13&15AA½<br />

1. Maricha (Fr.) 12 g<br />

2. Pippali (Fr.) 12 g<br />

3. Yavakshara (Yava) (Pl.) 6 g<br />

4. Dadima (Fr.R.) 24 g<br />

5. Guda 96 g<br />

Dose: 3 g (dissolved slowly in the mouth)<br />

important Therapeutic Uses:<br />

Kasa, Shvasa<br />

MARiCHADi GUTiKA<br />

(API Part I, Page 149)<br />

DADiMA (fruit Rind)<br />

(API Part I, Vol. - IV, Page 19)<br />

Dadima consists of dried fruit rind (pericarp) of Punica granatum Linn.<br />

(Fam. Punicaceae), a large deciduous shrub or a small tree, found wild in<br />

the warm valleys of the outer hills of Himalayas between 900 to 1800 m<br />

<strong>and</strong> also cultivated in many parts of the country.<br />

SyNoNyMS<br />

Sanskrit : Dantabija, Lohitapushpa<br />

Assamese : Dalim<br />

Bengali: Dadima, Dalimgach, Dalim<br />

English: Pomenagrate<br />

Gujrati: Dadam, Dadam phala<br />

Hindi: Anar, Anar-ke-per<br />

Kannada: Dalimba, Dalimbe haonu<br />

Malayalam: Mathalam<br />

Marathi: Dalimba<br />

Oriya: Dalimba<br />

Punjabi: Anar<br />

Tamil: Madulam Pazham<br />

Telugu: Dadimbakaya, Dadimma<br />

Urdu: Anar<br />

DESCRiPTioN<br />

a) Macroscopic<br />

Drug occurs in 0.1 to 0.5 cm thick, more or less concave, salver- shaped<br />

pieces, some pieces showing residual carpel walls <strong>and</strong> some having<br />

persistent toothed calyx tube alongwith withered stamens, styles <strong>and</strong> a<br />

few seeds; coriaceous, tough <strong>and</strong> nearly smooth; brown to reddish-brown<br />

externally <strong>and</strong> brownish-yellow internally; bearing impressions left by<br />

seeds; fracture, short; od<strong>our</strong> not distinct; taste, astringent.<br />

b) Microscopic<br />

Epicarp single layered covered with thick cuticle; mesocarp consists of<br />

a wide zone of oval to polygonal thin walled parenchymatous cells; a<br />

few fibro-vascular bundles, tanniniferous vessels, secretory canals, oil<br />

globules, single <strong>and</strong> a number of groups of round or oval to elongated<br />

stone cells, simple <strong>and</strong> compound starch grains having 2 or 3 components<br />

with concentric striations <strong>and</strong> central hilum, <strong>and</strong> rosette crystals of calcium<br />

oxalate present in mesocarp.<br />

Powder - Yellowish-brown; shows single or groups of stone cells; oval to<br />

polygonal, parenchymatous cells in surface view; vessels with scalariform<br />

thickening, tanniniferous vessels <strong>and</strong> a few rosette crystals of calcium<br />

oxalate <strong>and</strong> rounded to oval starch grains, measuring 3 to 5 μ in dia.<br />

iDENTiTy, PURiTy AND STRENGTH<br />

foreign matter: Not more than 2 per cent,<br />

Total Ash: Not more than 4 per cent,<br />

Acid-insoluble ash: Not more than 0.4 per cent,<br />

Alcohol-soluble extractive: Not less than 9 per cent,<br />

Water-soluble extractive: Not less than 20 per cent,<br />

T.l.C.<br />

T.L.C of alcoholic extract on Silica gel ‘G’ plate using Chloroform:<br />

Ethylacetate : Formic acid (5:4:1) shows in visible light one spot at Rf.<br />

0.74 (bluish grey). Under U.V. (366 nm) one fluorescent zone is visible<br />

at Rf. 0.74 (dark blue). On exposure to Iodine vap<strong>our</strong> two spots appear<br />

at 0.74 (dirty yellow) <strong>and</strong> 0.95 (yellow). On spraying with 10% aqueous<br />

Ferric chloride reagent one spot appears at Rf. 0.74.(blue). On spraying<br />

with 5% Mathanolic-Sulphuric Acid <strong>and</strong> heating the plate for ten minutes<br />

at 110°C two spots appear at Rf. 0.74 (brownish grey) <strong>and</strong> 0.95 (violet).<br />

CoNSTiTUENTS - Tannic acid, Sugar <strong>and</strong> Gum<br />

PRoPERTiES AND ACTioN<br />

Rasa: Kashaya, Amla<br />

Guna: Laghu, Snigdha<br />

Virya: Anushna<br />

Vipaka: Katu<br />

Karma: Vata Kaphahara, Vranaropaka, Grahi<br />

iMPoRTANT foRMUlATioNS - Khadiradi Gutika, Mritasanjivani<br />

Sura, Kalyanaka Ghrita, Marichadi Gutika, Nilikadya Taila<br />

THERAPEUTiC USES - Daha, Jvara, Katha Roga, Mukha daurg<strong>and</strong>hya,<br />

Aruchi, Amlapitta, Atisara, Pravahika, Raktapitta, Raktavikara, Kasa<br />

DoSE - Powder 3-6 g<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 9


GUDA (Jaggery)<br />

(API Part I, Vol. - VI, Page 206)<br />

Guda is obtained by concentrating juice expressed from the stems<br />

of Saccharum officinarum L. (Fam. Poaceae) with or without prior<br />

purification of the juice, followed by cooling.<br />

SyNoNyMS<br />

Ben: Guda<br />

Eng.: Jaggery<br />

Hin. : Guda<br />

Kan.: Bella<br />

Mal. : Sarkara<br />

Mar. : Guda<br />

Pun. : Guda<br />

Tam.: Vellam<br />

Tel.: Bellam<br />

Urdu: Guda<br />

DESCRiPTioN<br />

It is light yellow to reddish brown solid, blocks or spherical solid forms<br />

or in the form of coarse granules with pleasant <strong>and</strong> characteristic od<strong>our</strong>.<br />

It does not show the presence of insects, vegetable debris or fibers when<br />

examined with naked eyes in daylight.<br />

iDENTiTy, PURiTy AND STRENGTH<br />

loss on drying – Not more than 10 percent (other than that of the liquid<br />

or semi-liquid variety)<br />

Total Ash: Not more than 6 per cent,<br />

Acid-insoluble ash: Not more than 0.5 per cent,<br />

Water-soluble ash: Not less than 2 per cent,<br />

Total Sugar: Not less than 90 per cent,<br />

Sucrose: Not less than 60 per cent,<br />

Sulphur di oxide concentration: Not more than 70 ppm<br />

Heavy Metal: Complies with API<br />

Microbial limits: Complies with API<br />

Pesticide residue: Complies with API<br />

PRoPERTiES AND ACTioN<br />

Rasa: Madhura<br />

Guna: Snigdha, Isatksariya<br />

Virya: Naatishita<br />

Vipaka: Madhura<br />

Karma: Svadukara, Rakta shodhaka, Na atipittajajit, Kaphavriddhikara,<br />

Vataghna, Krimivrddhikara, Balya, Vrishya, Medovriddhikara<br />

iMPoRTANT foRMUlATioNS – Sarivadhyasava, Kumaryasava,<br />

Madhukasava<br />

THERAPEUTiC USES -Vata Roga (Diseases due to Vata Dosa),<br />

Daurbalya (weakness), Dhatukshaya (tissue wasting)<br />

DoSE – 5-30 g<br />

Storage- Should be stored preferably between 20 to 25 degree C, away<br />

from heat.<br />

yAVA (fruit)<br />

(API Part I, Vol. - II, Page 175)<br />

Yava consists of dried fruit of Hordeum vulgare Linn. Syn. H. sativum<br />

Pers. (Fam.Poaceae); an annual, erect herb, 50-100 cm high, cultivated<br />

chiefly in North India.<br />

SyNoNyMS<br />

Sanskrit : Dhanyaraja, Tikshnasuka¸Hayesta,<br />

Bengali : Jau, Jav<br />

English : Barley<br />

Gujrati : Cheno, Jau<br />

Hindi : Jav<br />

Malayalam : Javegambu<br />

Marathi : Yava, Java<br />

Punjabi : Javo<br />

Tamil : Barley<br />

Telugu : Barlibiyam, Yava Dhanya<br />

Urdu : Jau<br />

DESCRiPTioN<br />

a) Macroscopic<br />

Fruit a caryopsis, elliptic, oblong, ovoid-<strong>and</strong> tapering at both ends, smooth,<br />

about 1 cm long <strong>and</strong> 0.2-0.3 cm wide, dorsally compressed <strong>and</strong> flattened<br />

on the sides with a shallow longitudinal furrow, 3-5 ridges having shallow<br />

depression between them, grains tightly enclosed <strong>and</strong> adhering the lemma<br />

<strong>and</strong> palea; pale-greenish-yellow; od<strong>our</strong>, not distinct; taste, sweetishacrid.<br />

b) Microscopic<br />

fruit -Shows single layered epidermis consisting of crescent-shaped,<br />

round to oval wavy walled cells, followed by 2-3 layers, thick-walled,<br />

sclerenchymatous fibres; below the sclerenchyma are present irregular,<br />

square or quadrilateral, spongy parenchymatous cells, a few cell walls<br />

having silica bodies through which run the fibro-vascular bundles of the<br />

ribs, followed by more or less, polygortal inner epidermal cells, a few<br />

inner epidermal cells having unicellular claw-shaped hair <strong>and</strong> stomata;<br />

pericarp composed of cells with more or less compressed parenchymatous<br />

cells; seed coat appears as a col<strong>our</strong>less line; perisperm composed of cells<br />

with more or less wavy walls having narrow lumens; endosperm divided<br />

into two zones, 2-4 cells deep aleurone layers, <strong>and</strong> the rest starch layers;<br />

starch grains simple, round to oval, measuring 3-30 μ in diameter.<br />

Powder - Creamish-white; shows groups of fragments of polygonal, thinwalled<br />

flowering glume cells in surface view, sclerenchymatous fibres,<br />

scalariform vessels <strong>and</strong> abundant round to oval, simple starch grains,<br />

measuring 3-30 μ in diameter.<br />

iDENTiTy, PURiTy AND STRENGTH<br />

foreign matter: Not more than 2 per cent,<br />

Total Ash: Not more than 4 per cent,<br />

Acid-insoluble ash: Not more than 1.5 per cent,<br />

Water-soluble ash: Not less than 4 per cent,<br />

Alcohol-soluble extractive: Not less than 2.5 per cent,<br />

Water-soluble extractive: Not less than 5.5 per cent,<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 10


ASSAy<br />

T.l.C.<br />

T.L.C. of alcoholic extract of the drug on Silica gel ‘G’ plate using<br />

n-Butanol : Acetic acid: Water (4: 1 :5) shows under U.V. light (366 nm)<br />

seven fluorescent zones at Rf.0.10, 0.22, 0.31, 0.45, 0.68, 0.83 (all violet)<br />

<strong>and</strong> 0.92 (yellow).<br />

On spraying with Phosphomolybdic acid reagent <strong>and</strong> on heating the plate<br />

for ten minutes at 105°C six spots appear at Rf. 0.10, 0.22, 0.31, 0.68,<br />

0.83 <strong>and</strong> 0.92 (all grey). On spraying with Ninhydrin reagent eleven spots<br />

appear at Rf. 0.06, 0.14, 0.16, 0.24, 0.31, 0.36, 0.44, 0.53, 0.56, 0.65 &<br />

0.72 (all pink.)<br />

CoNSTiTUENTS - Starch, Sugars, Fats, Proteins (Albumin, Globulin,<br />

Prolamin <strong>and</strong> Glutilin) also contains Flavone Glycosides viz, Orientoside,<br />

Orientin, Vitexin etc.<br />

PRoPERTiES AND ACTioN<br />

Rasa: Kashaya, Madhura<br />

Guna: Ruksha, Guru, Picchila, Mridu<br />

Virya: Sita<br />

Vipaka: Katu<br />

Karma: Vatakrit, Pittahara, Kaphahara, Medohara, Balya, Vrishya,<br />

Svarya, Varnya, Sthairyakara, Purishkrit, Mutrahara, Lekhana<br />

iMPoRTANT foRMUlATioNS - Agastyaharitaki Rasayana, Eladya<br />

Modaka, Dadhika Ghrita, Dhanvantara Ghrita, G<strong>and</strong>harvahasta Taila,<br />

Dhanvantara Taila, Brihatmasa Taila, Sarshapadi Pralepa, Kayasthadya<br />

Vartti<br />

THERAPEUTiC USES - Medoroga, Prameha, Trishna, Urustambha,<br />

Kantharoga, Shvasa, Kasa, Pinasa, Tvagroga<br />

DoSE - 100 - 200 g of the drug.<br />

yAVAKSARA<br />

(API Part-II, Vol. - I, Page 111)<br />

Definition:<br />

Yavakshara is an alkaline preparation made with the ingredient in the<br />

Formulation composition given below.<br />

formulation composition:<br />

1. Yava (API) Bhasma Hordeum vulgare Pl. 1 part<br />

2. Jala API Water 6 parts<br />

Method of preparation:<br />

Take all ingredients of pharmacopoeial quality.<br />

Cut Yava into small pieces <strong>and</strong> dry completely. Burn to ash (Bhasma).<br />

Add 6 parts of water to Bhasma, stir well <strong>and</strong> keep over night.<br />

Next morning decant the clear liquid <strong>and</strong> filter through a three-layered<br />

muslin cloth.<br />

Repeat the filtering process till a col<strong>our</strong>less filtrate is obtained. Transfer<br />

filtered material to a stainless steel vessel <strong>and</strong> heat to evaporate the water.<br />

Collect kshara deposited as flakes from the bottom of the vessel <strong>and</strong> grind<br />

to a fine powder.<br />

Pack it in tightly closed containers to protect from light <strong>and</strong> moisture.<br />

Description:<br />

Greyish white, fine powder, passing through sieve number 100;<br />

hygroscopic, od<strong>our</strong>less, taste saline; freely soluble in water.<br />

Identification:<br />

An aqueous solution yields the reactions characteristic of sodium <strong>and</strong><br />

potassium,<br />

Physico-chemical parameters:<br />

loss on drying at 110º: Not more than 4 per cent,<br />

Acid-insoluble ash: Not more than 1 per cent,<br />

pH (10% aqueous solution): 9 to 10,<br />

Assay:<br />

Sodium: Not less than 17 per cent,<br />

Potassium: Not less than 16 per cent,<br />

Iron: Not less than 1.5 per cent,<br />

Storage: Store in a cool place in tightly closed containers, protected from<br />

light <strong>and</strong> moisture.<br />

Therapeutic uses: Adhmana (Flatulance); Anaha (distention of abdomen<br />

due to obstruction to passage of urine <strong>and</strong> stool); Shula (pain); Udara<br />

(diseases of abdomen); Gulma (Abdominal lump); Plihamaya (Splenic<br />

disease); Mutrakricchra (Dysuria).<br />

Dose: ½ to 1 g daily in divided dose.<br />

Anupana: Warm water, Ghrita.<br />

Laugh!<br />

it’s the best Medicine<br />

1000 Points to Get<br />

Into Heaven<br />

A man dies <strong>and</strong> goes to heaven when Peter meets him at the<br />

Pearly Gates. Peter says, “You need 1000 points to make it<br />

into heaven. You tell me all of the good things you’ve done,<br />

<strong>and</strong> I give you a certain number of points for each item.<br />

When you reach 1000 points, you get in.”<br />

“Okay,” the man says, “I was happily married to the same<br />

woman for fifty years <strong>and</strong> never cheated on her, not even<br />

in my mind.”<br />

“That’s wonderful,” says Peter, “that’s worth two points!”<br />

“Two points?” he says. “Well, I attended church all my life<br />

<strong>and</strong> gave my ten percent tithe faithfully.”<br />

“Terrific!” says Peter. “That’s definitely worth a point.”<br />

“One point? My goodness! Well, what about this: I started<br />

a soup kitchen in my city <strong>and</strong> worked in a shelter for the<br />

homeless?”<br />

“Fantastic, that’s good for two more points,” he says.<br />

“TWO POINTS!” the man cries. “At this rate the only way I<br />

can get into heaven is by the grace of God!”<br />

“Now that’s what we’re looking for! Come on in!”<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 11


MARiCHADi GUTiKA<br />

(API Part-II, Vol. - I, Page 98)<br />

DEfiNiTioN:<br />

Marichadi Gutika is a preparation made with the ingredients in the<br />

Formulation composition given below.<br />

formulation composition:<br />

1. Maricha API Piper nigrum Fr. 12 g<br />

2. Pippalī API Piper longum Fr. 12 g<br />

3.<br />

Yavakshara (Yava<br />

API)<br />

Pharmocopial St<strong>and</strong>ards For Marichadi Gutika<br />

Hordeum vulgare<br />

Bhasma of<br />

plant<br />

4. Dadima API Punica granatum Fr. R. 24 g<br />

5. Guda API Jaggery 96 g<br />

Method of preparation:<br />

Take all ingredients of Pharmacopoeial quality.<br />

Clean, dry, powder the ingredients no. 1, 2 & 4 of the formulation<br />

composition (Prakshepa Dravya) <strong>and</strong> pass through sieve number 85 to<br />

obtain fine powder.<br />

Collect Yava kshara in the specified ratio.<br />

Take jaggery, add required amounts of water, boil to dissolve <strong>and</strong> filter<br />

through a muslin cloth.<br />

Reduce to thicker consistency by gentle boiling to prepare Guda paka.<br />

Add fine powders of Prakshepa Dravya <strong>and</strong> Yavakshara <strong>and</strong> mix<br />

thoroughly to prepare a homogeneous mass.<br />

Pass the mass through a pill making machine <strong>and</strong> cut vatis of desirable<br />

weight. Roll the vatis on a flat surface by circular motion of palm. Dry the<br />

rolled vatis in a tray-dryer at a temperature not exceeding 600.<br />

Pack it in tightly closed containers to protect from light <strong>and</strong> moisture.<br />

Description:<br />

Spherical, soft, blackish brown col<strong>our</strong>ed pills with pleasant od<strong>our</strong> <strong>and</strong><br />

sweet taste.<br />

Identification:<br />

Microscopy:<br />

Take about five pills, crush, wash with water, clear in chloral hydrate, wash<br />

in water <strong>and</strong> mount in glycerin (80 per cent) <strong>and</strong> observe the following<br />

characters:<br />

Group of isodiameric or slightly elongated stone cells with moderately<br />

thickened walls, interspersed with thin walled polygonal parenchyma cells<br />

(Maricha); groups of elongated, spindle shaped, wide lumened lignified<br />

6 g<br />

stone cells (Pippali); groups of stone cells, oval shape, striated walls with<br />

minute central lumen (Dadima).<br />

Thin layer chromatography:<br />

Extract 5 g of the powdered pills with 70 ml of ethanol in soxhlet apparatus<br />

on a Water-bath for 6 h, filter <strong>and</strong> carry out thin layer chromatography.<br />

Apply 7.5 μl of the extract on TLC plate. Develop the plate to a distance<br />

of 8 cm using ethyl acetate: n-hexane: formic acid (4: 6: 0.1) as mobile<br />

phase. After development, allow the plate to dry in air <strong>and</strong> examine under<br />

ultraviolet light (254 nm). It shows major spots at Rf 0.14, 0.20 <strong>and</strong> 0.34<br />

(fluorescent green). Spray the plate with anisaldehyde- sulphuric acid<br />

reagent <strong>and</strong> heat at 1100 for about 10 min. The plate shows major spots<br />

at Rf 0.80 (blue), 0.65 (light violet), 0.52 (violet) <strong>and</strong> 0.11 (green) under<br />

visible light.<br />

Physico-chemical parameters:<br />

Loss on drying at 110º: Not more than 10 per cent,<br />

Total ash: Not more than 6 per cent,<br />

Acid-insoluble ash: Not more than 1 per cent,<br />

Alcohol-soluble extractive: Not less than 9 per cent,<br />

Water-soluble extractive: Not less than 46 per cent,<br />

Assay:<br />

Not less than 2.83 per cent of piperine when assayed by the following<br />

method.<br />

Estimation of Piperine: Dissolve 2.5 mg of piperine in a mixture of<br />

methanol: Chloroform (1 : 1) <strong>and</strong> make up the volume to 25 ml in a<br />

volumetric flask. Apply 2, 5, 8,11, 14, 17 μl of solution on TLC plate <strong>and</strong><br />

develop the plate a distance of to 8 cm using acetone : n-hexane (3 : 7) as<br />

mobile phase. After development, dry the plate in a current of hot air <strong>and</strong><br />

scan in the TLC scanner at a wavelength of 338 nm. Note the peak area<br />

<strong>and</strong> prepare the calibration curve by plotting peak area vs concentration<br />

of piperine.<br />

Extract accurately weighed about 6 g powder of vatis in 100 ml of alcohol in<br />

a Soxhlet apparatus for 6 h. Filter the extract while hot <strong>and</strong> dry completely<br />

<strong>and</strong> weigh. Take 25 mg of extract in a volumetric flask <strong>and</strong> dissolve in a<br />

mixture of methanol: chloroform (1: 1) <strong>and</strong> make up the volume to 25 ml.<br />

Apply 3 μl of the test solutions on TLC plate. Develop, dry <strong>and</strong> scan the<br />

plate as described in the proceeding paragraph for calibration curve of<br />

piperine. Record area under the curve for a peak corresponding to piperine<br />

in the test solution. Calculate the amount of piperine in the test solution<br />

from the calibration curve of piperine.<br />

other requirements:<br />

Microbial Limits: As per prescribed limits<br />

Aflatoxins: As per prescribed limits<br />

Storage: Store in a cool place in tightly closed containers, protected from<br />

light <strong>and</strong> moisture.<br />

Therapeutic uses: Kasa (cough); Shvasa (Asthma).<br />

Dose: 3 g per day – to be dissolved slowly in the mouth.<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 12


A R<strong>and</strong>omized, Comparative, Open Clinical Study for Evaluation of Efficacy of<br />

DRF/Ay/4010 & 4012 (Dabur Rheumatil Gel & Dabur Rheumatil Tablet) in the<br />

Management of Osteoarthritis<br />

Authors:<br />

Dr. Arun Gupta* MD. (Ay.) Dr. Rajesh Thahal* BAM S Dr. J.L.N. Sastry** M.D. (Ay.)<br />

Dr. Gaurav Sharma** MD. (Ay) Dr. Manju Rakesh** BAMS Dr. K.R. Kohli** MD (Ay.) Ph.D<br />

*Department of Kayachikitsa (Internal Medicine), Shri Dhanwantary Ayurvedic College <strong>and</strong> Dabur Dhanwantari Hospital, Sector 46, Ch<strong>and</strong>igarh, India.<br />

** Dabur Research Foundation, Sahibabad - 201010, Ghaziabad, (U.P.), India.<br />

1. iNTRoDUCTioN:<br />

Arthritis is an inflammation of a joint characterized by pain, swelling<br />

<strong>and</strong> limitation of joint movement. Varied etiologic factors have been<br />

implicated in the pathogenesis of this condition. Osteoarthritis (OA) <strong>and</strong><br />

Rheumatoid Arthritis (RA) are the main entities. Osteoarthritis, the most<br />

common joint disease, presenting with symptoms of Joint pain, Stiffness<br />

in the joints, Instability of the joint, Loss of normal function of the joint,<br />

Limitation of motion, Crepitus, morning stiffness of the joints, Instability<br />

or giving way of the joint, Joint enlargement or deformity.<br />

In Ayurveda osteoarthritis is comparable with the condition known<br />

as s<strong>and</strong>hi vata (SV). Apart from SV, we come across other important<br />

conditions like Vatarakta (Gout) <strong>and</strong> Amavata (Rheumatoid arthritis) in<br />

the Ayurvedic texts. S<strong>and</strong>hi or articulation is considered to be the union<br />

between Asthi (bone), Snayu (ligament) & K<strong>and</strong>ara (tendon). It is also<br />

explained that sleshmadhara kala (synovial membrane) <strong>and</strong> sleshaka<br />

sleshma (synovial fluid) are present in each joint. Asthi Dhatu is considered<br />

to be the asrayee of vata dosha. Asthivaha srotas is related to medas <strong>and</strong><br />

medovaha srotas is related to vrikka (renal & suprarenal). Supra-renal<br />

gl<strong>and</strong> is known for its involvement in fat <strong>and</strong> calcium metabolism. Majja<br />

(bone marrow) is the medas inside asthi. Therefore, asthi is mula for<br />

majjavaha srotas. Snayu (ligament) is the upa dhatu of medas. Nakha &<br />

roma are the malas of asthi. This inter-play is critical in the management<br />

of S<strong>and</strong>hivata. There are various symptoms related to s<strong>and</strong>hi (joints) like<br />

s<strong>and</strong>hib<strong>and</strong>ha moksha (laxity of joints), s<strong>and</strong>hi bheda (scalding pain in<br />

joints), s<strong>and</strong>hi atopa (severe pain in joints), s<strong>and</strong>hi hani (reduction in joint<br />

mobility), s<strong>and</strong>hi hata (immobility of joints), s<strong>and</strong>hi nistoda (vasospastic<br />

pain in joints), s<strong>and</strong>hi sopha (swollen joints), s<strong>and</strong>hi sula (painful joints),<br />

s<strong>and</strong>hi sphurana (tremors in joints), s<strong>and</strong>hi sphutana (cutting type pain<br />

in joints) etc.<br />

NSAIDs form the mainstay of treatment but may prove ineffective in<br />

some patients <strong>and</strong> have varied gastrointestinal <strong>and</strong> systemic adverse<br />

effects. Hence there appears a need for a drug with good efficacy <strong>and</strong><br />

low toxicity in the treatment of OA. Specifically, there is a need for safe<br />

<strong>and</strong> effective drugs for patients who do not respond well to conventional<br />

medical therapy. Hence there is an increase in usage of complementary/<br />

alternative medicines.<br />

According to Ayurvedic texts, Agni Karma (thermal cautery) <strong>and</strong> Upanaha<br />

Sweda (poultice fomentation) are the first <strong>and</strong> second among line of<br />

treatments. Several Panchakarma procedures were tried earlier to find out<br />

their role in the management of SV. Apart from these procedures, there<br />

are certain classical formulations were also studied for their efficacy in<br />

the management of SV (OA) e.g. Simhanada guggulu, Amritadi guggulu,<br />

Trayodashanga guggulu , Ajmodadi chuma, Sunthi guggulu, Shallaki<br />

etc.<br />

It is observed that many of the patients suffering from OA try the<br />

alternative medicines for relief. Most of the Ayurvedic prescriptions<br />

range from guggulu preparations for oral administration to oil massages<br />

externally. In the medical treatment, usage of either Lakshadi guggulu or<br />

Abha guggulu along with Rasayan drugs like Aswag<strong>and</strong>ha or Guduchi<br />

are also found to be <strong>very</strong> useful. External application is made of oils like<br />

Mahanarayana taila, Maha Vishagarbha taila, Nirgundi taila, Karpuradi<br />

taila, Ch<strong>and</strong>anbala Lakshadi taila, Pinda taila etc.<br />

Limitations in the conventional medical management of osteoarthritis<br />

indicate a real need for safe <strong>and</strong> effective treatment to the patients. Herbal<br />

medicines may provide a good alternative in this condition. Hence the<br />

present study is planned to evaluate the efficacy of DRF/AY/4010 (Dabur<br />

Rheumatil Gel) <strong>and</strong> DRF/AY/4012 (Dabur Rheumatil Tablet) alone <strong>and</strong><br />

in combination aiming at the comprehensive management of s<strong>and</strong>hivata<br />

(Osteoarthritis).<br />

2. MATERiAl AND METHoDS:<br />

Subjects (n=90) suffering from OA were selected from the OPD of the<br />

department of Kaya Chikitsa, Dabur-Dhanwantry Ayurvedic Hospital,<br />

Ch<strong>and</strong>igarh.<br />

Study Design: Open, comparative, r<strong>and</strong>omized prospective clinical trial.<br />

2.1. inclusion & exclusion criteria for study subjects:<br />

Male or Female patients >30 years of age, complaining of Knee pain<br />

with clinical or laboratory finding, suffering from mild to moderate OA<br />

involving knee joint with symptoms of pain, swelling, tenderness <strong>and</strong><br />

morning stiffness, of one or more joints, which may have lasted for more<br />

than 2 weeks were included in the study. Patients with serious medical<br />

illness (HIV, Diabetes, SLE, Rheumatoid Arthritis, Rheumatic Fever,<br />

Psoriatic Arthritis), surgical illness where compliance is difficult, taking<br />

part in any other study or taking any other medication for the treatment of<br />

arthritis were excluded from the study.<br />

2.2. Study Groups:<br />

• Group A: Combipack (DRF/AY/4010 gel & DRF/AY/4012 tab) was<br />

given. Tablets were administered orally in a dosage of 2 b.i.d., <strong>and</strong> gel<br />

applied in adequate quantity (approximately 2 cm) twice a day.<br />

• Group B: Treatment with DRF/AY/4012 tablets orally in a dose of 2<br />

tab. b.i.d.<br />

• Group C: About 2 cm DRF/AY/4010 gel will be applied gently over<br />

affected part twice daily (in the morning <strong>and</strong> at night).<br />

2.3 Study End points:<br />

• Therapeutic End Points: 4 weeks usage of the formulation with or<br />

without relief from the symptoms<br />

• Clinical End Points: Relief from symptoms of OA within 4 weeks of<br />

treatment with interventional drugs.<br />

3. oBSERVATioNS AND RESUlTS:<br />

Subjects (n=90) belonging to both the sex suffering from osteoarthritis<br />

knee were included in this study. The female to male ratio in group A, B &<br />

info Ayurveda, Volume 2, No. 2, Oct.-Dec.,’ 2012 13


C was 6:1; 4:1 & 3.5:1 respectively. The mean age in all the three groups<br />

is tabulated below:<br />

Table 1: Age <strong>and</strong> Sex distribution in all the three groups<br />

Female Male<br />

Group A (CoMBiPACK)<br />

No of patients 23 4<br />

Mean Age 50.52 ±9.751 64.8 ±9.5<br />

Group B (TAB)<br />

No of patients 24 6<br />

Mean Age 49.5 ±11.51 53.67 ±18.94<br />

Group C (GEl)<br />

No of patients 21 6<br />

Mean Age 49.05 ±12.71 56.33 ±6.47<br />

In total, there were 6 dropouts at the end of the study, 3 in group A <strong>and</strong> 3<br />

in group C.<br />

The following are the observed results on the following parameters:<br />

3.1. improvement in the intensity of pain at movement:<br />

It was observed that maximum VAS score reduction on pain at movement<br />

was reported in Group A (Combipack Group) i.e. 27.78. This reduction<br />

was 25.00 <strong>and</strong> 22.95 in Group B (Tablet Group) <strong>and</strong> Group C (Gel Group)<br />

respectively. The reduction in VAS scores was found to be statistically<br />

significant (p


3.6. improvement in the walking time:<br />

The reduction in walking time was 13.36 sec in Group A. It was 9.79 sec.<br />

in Group B <strong>and</strong> 11 .81 sec in Group C. The reduction was found to be<br />

statistically significant (p


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