DOI: 10.4103/dypj.dypj_33_25 ISSN: 2347-3665

Prospective, Randomized, Multi-centric, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of KSM-66 Ashwagandha (Withania somnifera) in Adults Experiencing High Stress and/or Anxiety: Clinical Study Protocol

Deepak Langade, Jaising Salve, Prasanthi Sampara
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Abstract

Background:

Modern life often leads to stress, manifesting physical symptoms like fatigue and headaches, as well as emotional effects such as anxiety and mood changes. Ashwagandha ( Withania somnifera ), a key medicinal plant in Indian Ayurveda, is renowned for its anti-stress and vitality-enhancing properties. This study aims to assess the efficacy and safety of Ashwagandha root extract in adults experiencing high stress and anxiety.

Materials and Methods:

This study is a prospective, randomized, multi-national, multi-center, double-blind, placebo-controlled trial designed to assess the safety and tolerability of Ashwagandha ( Withania somnifera ) root extract (ARE) in adults across different populations. The primary focus of the overall trial is on stress and anxiety reduction; this segment specifically investigates the safety and tolerability of ARE in an adult population. A total of 1000 subjects with anxiety and stress disorders were enrolled in the study.

Conclusion:

This study will provide compelling evidence that KSM-66 Ashwagandha root extract is a safe and well-tolerated intervention for reducing stress and managing anxiety in healthy adults.

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