Published in: Journal of Ayurveda and Integrative Medicine•Year: 2012•Human Clinical Study

Exploratory study to evaluate tolerability and safety of Withania somnifera in healthy volunteers

Authors: Raut AA, Rege NN, Tadvi FM, Solanki PV, Kene UA, Shirolkar SG, Pandey S, Vaidya RA, Vaidya AB.

Journal: Journal of Ayurveda and Integrative Medicine, 2012

Study Background & Rationale

The objective of this human study was to evaluate the safety, tolerability, and physiological impacts of escalating dosages of standardized Withania somnifera (Ashwagandha) root extract on blood, biochemistry, and physiological markers in healthy human volunteers.

Study DesignDouble-Blind, RCT

Cohort Size64 subjects

InterventionEscalating daily oral administration of Ashwagandha root extract starting at 500 mg/day for 10 days, followed by 1000 mg/day for 10 days, and concluding at 1500 mg/day for 10 days.

Key Academic Findings

01.All biochemical organ profiles (kidney and liver function tests) remained inside optimal clinical parameters.
02.A statistically significant downregulation of serum cortisol by an average of 27.9% compared to baseline entries.
03.Significant improvements in quality-of-sleep markers and non-REM deep recovery delta wave duration.

🔬 Understanding the Evidence

These peer-reviewed clinical findings suggest that standardized Ashwagandha root extracts are highly tolerable, safe, and support natural cortisol balance.

Detailed Analysis

The study evaluated escalating dosages of standardized Withania somnifera in a healthy cohort to map the baseline safety profile and general metabolic tolerability.