Clinical trial on healthy subjects for general health
- Registration Number
- CTRI/2021/02/031064
- Lead Sponsor
- IndusViva HealthSciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1.Men and women aged 18-55 years
2.Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the investigator
3.Subject willing to provide written informed consent and comes for regular follow up
1.A know history or present condition of allergic response to any pharmaceutical products and supplements.
2.History of major cardiovascular events in the last 1 year (stroke or myocardial infraction).
3.Gastrointestinal(i.e. inflammatory bowel disease, celiac), liver(ASL/ALT above two times the upper limit of normal) or kidney disease (eGFR < 60 ml/min/1.73 k/m2).
4.Cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure).
5.Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
6.Post-menopausal female subjects.
7.History of drug dependence or any severe co-morbid medical conditions.
8.High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine/Caffeine dependence or chronic smoker.
9.Administration of any other multivitamins/herbal product/wellness products
10. Subject has participated in a clinical study within the last 30 days prior to entering this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety of iVed in healthy human subjects <br/ ><br>from baseline to end of the trial <br/ ><br>Timepoint: Baseline, 4 weeks and 8 weeks <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the general health maintenance based on <br/ ><br>Quality of Life Questionnaire.Timepoint: Day 0 and Day 60