Actively Recruiting
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
Led by SF Research Institute, Inc. · Updated on 2024-12-04
51
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
S
SF Research Institute, Inc.
Lead Sponsor
A
Agaja Pharma Pvt. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (male and female) aged between 18 and 65 years.
- Experiencing signs and symptoms suggestive of stress such as difficulty concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, or mental confusion.
- Hamilton Anxiety Rating Scale (HAM-A) total score between 14 and 30 at screening.
- Perceived Stress Scale (PSS) score of 13 or higher at screening.
- Body mass index (BMI) between 20 and 35.
- No plans to start new treatments during the study period.
- Medication-free from any drugs affecting stress and anxiety for at least 4 weeks; occasional use of analgesics (once a week) or contraceptive pills allowed.
- Ability and willingness to sign informed consent and comply with study procedures.
You will not qualify if you...
- Use of medications known to affect stress and anxiety (corticosteroids, antidepressants, antipsychotics, mood stabilizers, anti-epileptic drugs) within 4 weeks before screening.
- Hamilton Anxiety Rating Scale (HAM-A) score less than 14 at screening.
- Use of over-the-counter herbal extracts like Ginkgo Biloba, St. John's Wort, Omega-3 within 4 weeks before screening.
- Diagnosis of depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsive disorder, alcohol dependency, schizophrenia, or mania.
- Known post-traumatic stress disorder (PTSD) or generalized anxiety disorder (GAD).
- Regular practice of meditation or relaxation techniques for three or more months.
- Clinically significant acute unstable liver, kidney, heart, or lung disease preventing study participation.
- History of alcohol, tobacco dependence, or substance abuse.
- Pregnant, breastfeeding, or suspected pregnancy.
- Known allergy to Ashwagandha.
- Participation in other clinical trials within the past 3 months.
- Any clinical condition judged by the investigator to prevent safe participation in the trial.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
San Francisco Research Institute
San Francisco, California, United States, 94127
Actively Recruiting
Research Team
J
John Ademola
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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