Evaluating the safety of Ashwagandha root extract in healthy adults
Safety of Ashwagandha (Withania Somnifera) Root Extract: An Open-Label, Non-Comparative, Prospective Study in Healthy Subjects
This study is testing if taking 500 mg capsules of Ashwagandha root extract is safe for healthy adults over 12 weeks while also checking how it might improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | SF Research Institute, Inc. Research network |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06261476 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over a 12-week period. Participants will undergo various laboratory tests, including Complete Blood Count, Renal Function Test, and Liver Function Test, to monitor safety. Additionally, the study will evaluate the impact of Ashwagandha on the Quality of Life using the SF-36 tool. A total of 100 healthy subjects aged 18 to 65 will be enrolled across two sites.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 who do not have any chronic illnesses.
Not a fit: Patients with chronic illnesses or those taking medications that could affect the study's safety outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for the safe use of Ashwagandha as a dietary supplement in healthy individuals.
How similar studies have performed: While there is limited data on the safety of Ashwagandha in healthy populations, previous studies have shown promising results regarding its safety and efficacy in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Both adults (male and female) aged between 18 and 65 years. * Participant should be healthy and free from any chronic illness, such as diabetic, cardiovascular or any other condition that could affect the safety of the study. * No plan to commence any other alternative treatment modality for their conditions. * Willingness to sign an informed consent document and to comply with all study related procedures. Exclusion Criteria: * History of Alcohol or smoking abuse. * History of hypersensitivity to Ashwagandha. * Taking nutritional or energy supplements, medication, or steroids. * Any history of drug abuse. * Having any clinical abnormalities. * Simultaneously participating in any other clinical trial or participated in the past three months. * Participants who use medication for blood pressure, use betablockers, inhaled any beta-agonists, use any hormonal contraceptives, having a history of corticosteroid use within three months, participants under psychotropic medication within last 8 weeks, and * Participants diagnosed with any heart disease, diabetes, stroke, neurological disorders or depression. * Have clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study. * Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder, alcohol dependency; schizophrenia and mania. * Patients with post traumatic disorder. * Have an established practice of meditation for three or more months. * Pregnant and lactating women. * Participation in other clinical trials during previous 3 months. * Any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol.
Where this trial is running
San Francisco, California
- SF Research Institute — San Francisco, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.