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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.
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
Interventions
Proprietary Blend of Ashwagandha
One capsule (300mg) is taken twice daily with water
KSM-66 Ashwagandha root extract
One capsule (300mg) is taken twice daily with water
Placebo
One capsule (300mg) is taken twice daily with water
Locations (1)
San Francisco Research Institute
San Francisco, California, United States