RecruitingNot ApplicableNCT06714942

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.

Enrollment

51 participants

Start Date

Oct 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a supplement made from ashwagandha root extract can reduce stress and anxiety in adults. Ashwagandha is a herbal plant traditionally used in Ayurvedic medicine, and this trial aims to rigorously test whether it works better than a placebo. **You may be eligible if...** - You are 18–65 years old - You are experiencing signs of stress and anxiety (e.g., difficulty concentrating, fatigue, restlessness, insomnia) - Your anxiety score on the HAM-A scale is between 14 and 30 - Your stress score on the PSS scale is 13 or above - You have a BMI between 20 and 35 - You have not taken any stress- or anxiety-related medications for at least 4 weeks **You may NOT be eligible if...** - You are currently taking antidepressants, antipsychotics, or anti-epileptic medications - You have a diagnosis of depression with suicidal tendencies, schizophrenia, or panic disorder - You have been taking herbal supplements like St. John's Wort or Ginkgo Biloba recently - You have serious medical conditions like liver disease, thyroid disease, or diabetes - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTProprietary Blend of Ashwagandha

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

DIETARY_SUPPLEMENTKSM-66 Ashwagandha root extract

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

DIETARY_SUPPLEMENTPlacebo

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


Locations(1)

San Francisco Research Institute

San Francisco, California, United States

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NCT06714942


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