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Herbal Supplement
Ashwagandha for Anxiety
N/A
Recruiting
Research Sponsored by SF Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults (male and female) aged between 18 and 65 years
Be older than 18 years old
Must not have
Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study
Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, antipsychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pss assessment will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4), and visit 3 (week 8).
Summary
"This trial is testing the effectiveness and safety of a special blend of Ashwagandha root extract for adults with high stress and anxiety. Participants will be randomly assigned to one of three groups and will
Who is the study for?
Adult men and women experiencing high levels of stress and anxiety can join this trial. They must understand the study's purpose, agree to take capsules twice daily for 8 weeks, and sign a consent form. Specific details on who can't participate are not provided.
What is being tested?
The trial is testing the effectiveness of two forms of Ashwagandha root extract against a placebo in reducing stress and anxiety over an 8-week period. Participants will be randomly assigned to one of three groups: proprietary blend, KSM-66 extract, or placebo.
What are the potential side effects?
Potential side effects are not detailed here but typically could include digestive discomfort or allergic reactions given that Ashwagandha is an herbal supplement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe liver, kidney, heart, or lung problems that would stop me from joining the study.
Select...
I have not taken medication for stress, anxiety, or mood disorders in the last 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pss assessment will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4), and visit 3 (week 8).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pss assessment will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4), and visit 3 (week 8).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Hamilton Anxiety Rating Scale (HAM-A)
Oxford Happiness Questionnaire
Perceived Stress Scale Score (PSS)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment1 Intervention
One capsule of Proprietary Blend of Ashwagandha 300 mg twice a day, orally with water.
Group II: Comparator GroupExperimental Treatment1 Intervention
One capsule of KSM-66 Ashwagandha 300mg two times a day, orally with water
Group III: Control GroupPlacebo Group1 Intervention
One capsule of Placebo two times a day, orally with water
Find a Location
Who is running the clinical trial?
SF Research Institute, Inc.Lead Sponsor
6 Previous Clinical Trials
491 Total Patients Enrolled
1 Trials studying Anxiety
50 Patients Enrolled for Anxiety
Agaja Pharma Pvt. Ltd.UNKNOWN