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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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.

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.

Find a Location

Who is running the clinical trial?

SF Research Institute, Inc.Lead Sponsor
4 Previous Clinical Trials
340 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the eligibility criteria to participate in this experimental study?

"To be considered for enrollment, individuals must meet the criteria of being healthy volunteers aged between 18 and 65. The aim is to recruit approximately 100 participants for this research project."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"As per the details on clinicaltrials.gov, this investigation is actively seeking volunteers. The trial was initially listed on 2/1/2024 and most recently modified on 2/7/2024."

Answered by AI

Are individuals above the age of 30 eligible to participate in this medical study?

"Participants aged between 18 and 65 are eligible for enrollment in this study. Conversely, there are a total of 65 trials targeting individuals under 18 years old and 379 studies focusing on those over the age of 65."

Answered by AI

What is the current total number of participants being recruited for this clinical study?

"Indeed, information available on clinicaltrials.gov highlights the ongoing recruitment status of this particular trial. The initial posting date for this study was 1st February 2024 with the most recent update recorded on 7th February 2024. This trial aims to enroll a total of 100 participants from one site."

Answered by AI

Who else is applying?

What site did they apply to?
SF Research Institute
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am interested in ashwanda root or however it’s spelled.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Safety of Ashwagandha (Withania Somnifera) Root Extract
2024. "Safety of Ashwagandha (Withania Somnifera) Root Extract". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06261476.
All > Sacramento
~0 spots leftby May 2024
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