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

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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