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RECRUITING
NCT06714942
NA

Efficacy and Safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women With High Stress and Anxiety: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study

Sponsor: SF Research Institute, Inc.

View on ClinicalTrials.gov

Summary

This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women with High Stress and Anxiety. All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. Subjects will be informed about the purpose of the study and signed informed consent will be taken. Subjects will be randomized to either one of the three treatment arms. Subjects will then be asked to either take one capsule containing the proprietary blend of Ashwagandha root extract or Ashwagandha root extract or Placebo orally twice daily with a glass of water for 8 weeks. The primary objective is to compare the efficacy of a proprietary blend of Ashwagandha root extract in adults experiencing stress and anxiety. The secondary objective is to compare the safety of a proprietary blend versus KSM-66 versus Placebo in adults experiencing stress and anxiety.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2024-10-25

Completion Date

2025-01-21

Last Updated

2024-12-04

Healthy Volunteers

Yes

Conditions

Interventions

DIETARY_SUPPLEMENT

Proprietary Blend of Ashwagandha

One capsule (300mg) is taken twice daily with water

DIETARY_SUPPLEMENT

KSM-66 Ashwagandha root extract

One capsule (300mg) is taken twice daily with water

DIETARY_SUPPLEMENT

Placebo

One capsule (300mg) is taken twice daily with water

Locations (1)

San Francisco Research Institute

San Francisco, California, United States