Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers

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 ×10 days, 1 000 mg/day × 10 days, 1 250 mg/day × 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 One volunteer showed increased appetite, libido, and hallucinogenic effects with vertigo at the lowest dose and was withdrawn from study.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 significant. 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.

AshwaMAX and Withaferin A inhibits gliomas in cellular and murine orthotopic models

“…This finding is congruent with reports in the literature showing a general lack of toxicity with treatment by similar or same formulations of winter cherry tree extracts [11, 39–41] in humans. The research results, in aggregate, strengthens the validity in utilizing a natural plant extract such as AshwaMAX to treat gliomas.…”

Synergistic inhibition of glioma cell proliferation by Withaferin A and tumor treating fields

“…However, withanolides are effective against different cell culture strains of cancers [35] as well as in numerous preclinical models of murine and human cancer xenografts [36], including human GBM [11]. Such investigations have also included toxicity studies in preclinical models[37, 38] and in clinical subjects [39, 40]. In general, these studies showed good tolerability to oral doses of either purified Withaferin A or Withania extracts that contain withanolides with minimal side effects Future preclinical and clinical investigations should include investigating the impact of metabolism on efficacy of Withaferin A [35].…”

An Alternative Treatment for Anxiety: A Systematic Review of Human Trial Results Reported for the Ayurvedic Herb Ashwagandha (Withania somnifera)

“…The conclusion that WS is a safe herbal supplement for general use agrees with findings from a recent evaluation of the tolerability and safety of WS in human participants. 21 Additional research is needed to determine standardization of WS supplements and dosage recommendations.…”