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.
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.
Intervention Protocol
Escalating 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.
📊 Primary Outcome
27.9% reduction in morning cortisol levels; significant sleep scores improvement.
🔬 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.
⚠️ Research Integrity Notice
This is a plain-language summary of a published study for educational purposes. It is not a substitute for professional medical advice or direct consultation of the original peer-reviewed paper.
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