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• 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 info Ayurveda, Volume 2, No.5, July - Sept’ 2013 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, New Delhi, Edn. 2 nd , Reprint Aug 1999, PP-32. 11. Bharat Bhaishajya Ratnakar, Translated by Gopinath gupta –Vol IV –B, Jain Publishers, New Delhi, Edn. 2 nd , Reprint Aug 1999, PP-119. 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 info Ayurveda, Volume 2, No.5, July - Sept’ 2013 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
Page 1 and 2: Volume 2, No.5, July to September
Page 3 and 4: Regulatory Update REGISTRATION OF C
Page 5 and 6: GOOD CLINICAL PRACTICE GUIDELINES F
Page 7 and 8: STORAGE Store in a cool place in ti
Page 9 and 10: BRIEF REVIEW ON ASHWAGANDHA (Withan
Page 11: urinary stones and hemorrhagic dise
Page 15 and 16: 3.6. TOLERANCE The drug was well to

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