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Herbal Supplement

Ashwagandha (Withania somnifera) Root Extract for Healthy Subjects

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
Participant should be healthy and free from any chronic illness, such as diabetes, cardiovascular disease, or any other condition that could affect the safety of the study
Must not have
Taking nutritional or energy supplements, medication, or steroids
Clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

"This trial will assess the safety of Ashwagandha root extract capsules in healthy adults over a 12-week period by analyzing various blood tests. Additionally, the study will look at the overall safety

Who is the study for?
This trial is for healthy adults who want to participate in a study evaluating the safety of Ashwagandha root extract over a 12-week period. Participants will undergo various health tests, including blood counts and organ function assessments.Check my eligibility
What is being tested?
The trial is testing the effects of taking 500 mg capsules of Ashwagandha root extract on laboratory markers like blood count, kidney and liver functions, cholesterol levels, thyroid hormones, fasting blood sugar, and HbA1c as well as its impact on quality of life.See study design
What are the potential side effects?
Potential side effects are not specified but may be identified through comprehensive health monitoring during the trial. These could include changes in lab test results indicating impacts on organ function or other aspects measured.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I am healthy and do not have chronic illnesses like diabetes or heart disease.
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I am not planning to start any alternative treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking supplements, medication, or steroids.
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I do not have any severe liver, kidney, heart, or lung conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alkaline Phosphatase Test
Aspartate Transaminase Test
Bilirubin Test
+17 more
Secondary outcome measures
Adverse Events
Quality of Life (SF-36 QoL)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ashwagandha (Withania somnifera) Root ExtractExperimental Treatment1 Intervention
Participants will take two Ashwagandha capsules containing 500 mg standardized root extract twice daily after breakfast and dinner, for a duration of 12 weeks.

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Who is running the clinical trial?

SF Research Institute, Inc.Lead Sponsor
4 Previous Clinical Trials
340 Total Patients Enrolled
~67 spots leftby Jul 2025
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