To study the safety of Ashwagandha extract in healthy people
- Registration Number
- CTRI/2022/08/044636
- Lead Sponsor
- Arjuna Natural Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
1. Males or females above 18 and below 55 years of age.
2. Individuals who have been tested negative for SARS-COV2 in a RT-PCR test.
3. Volunteer must be able, willing and likely to fully comply with study procedures and restrictions.
4. Voluntariness to participate in the trial and give signed informed consent.
5. No clinically significant abnormalities judged by the principal investigator based on the medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
1. Individuals who have been tested positive to be infected with SARS-COV2 in a RT-PCR test.
2. Patients with history of co-morbid illnesses such as cardiovascular, endocrine, renal, hepatic or other chronic disease likely to affect stress/anxiety or limit normal function.
3. Individuals with history of serious complications of diseases such as cancer, heart disease, infraction, stroke, arterial fibrillation, cardiac arrhythmia, disabilities, neurodegenerative disease.
4. Subjects with alcohol and/or substance dependence.
5. Subjects with known allergic reactions to test drug or any of its ingredients or any other herbal supplements.
6. Undergone surgery during last one year.
7. Individuals participating in any other clinical trial.
8. Female volunteers who are found positive in Urinary Pregnancy Test or are lactating.
9. Any condition, including laboratory abnormalities, that in the opinion of investigator places the volunteer at an unacceptable risk or deems the volunteer not suitable for participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the safety parameters from baseline to endpoint compared within-group at each timepointTimepoint: Baseline, day 30, day 60 and day 90
- Secondary Outcome Measures
Name Time Method Determination of tolerability of test product by observing and assessing the occurrence of adverse <br/ ><br>eventsTimepoint: Through-out the treatment duration till last dose;Dietary intake assessmentTimepoint: Baseline, day 30, day 60 and day 90;Frequency and severity of adverse events and serious adverse eventsTimepoint: Through-out the treatment duration till last dose