Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers.
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Date
2012-07
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Abstract
Ashwagandha (Withania somnifera) (WS), a “rasayana” drug, is recommended for balavardhan and mamsavardhan. The
study was intended to evaluate dose-related tolerability, safety, and activity of WS formulation in normal individuals.
The design was prospective, open-labeled, variable doses in volunteers. Eighteen apparently healthy volunteers (12M:6F,
age:18-30 years, and BMI: 19-30) were enrolled. After baseline investigations, they received WS capsules (Rx) (aqueous
extract, 8:1) daily in two divided doses with increase in daily dosage every 10 days for 30 days (750 mg/day x10 days,
1 000 mg/day x 10 days, 1 250 mg/day x 10 days). Volunteers were assessed for symptoms/signs, vital functions,
hematological and biochemical organ function tests. Muscle activity was measured by hand grip strength, quadriceps
strength, and back extensor force. Exercise tolerance was determined using cycle ergometry. Lean body weight and fat%
were computed from skin fold thickness measurement. Adverse events were recorded, as volunteered by the subjects.
Repeated measures ANOVA, McNemar’s test, and paired t test were employed. All but one volunteer tolerated WS without
any adverse event. One volunteer showed increased appetite, libido, and hallucinogenic effects with vertigo at the lowest
dose and was withdrawn from study. In six subjects, improvement in quality of sleep was found. Organ function tests
were in normal range before and after the intervention. Reduction in total- and LDL- cholesterol and increase of strength in
muscle activity was signifi cant. Total body fat percentage showed a reduction trend. WS, in escalated dose, was tolerated
well. The formulation appeared safe and strengthened muscle activity. In view of its traditional Rasayana use, further
studies are planned to evaluate potential of this drug in patients of sarcopenia.
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Keywords
Ayurvedic plant drug, exercise tolerance, muscle activity, muscle strength, Rasayana drug, Withania somnifera
Citation
Raut Ashwinikumar A, Rege Nirmala N, Tadvi Firoz M, Solanki Punita V, Kene Kirti R, Shirolkar Sudatta G, Pandey Shefali N, Vaidya Rama A, Vaidya Ashok B. Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers. Journal of Ayurveda and Integrative Medicine. 2012 July-Sept; 3(3): 111-114.