A clinical study to evaluate the safety of Puremeric in Healthy volunteers
- Registration Number
- CTRI/2019/10/021611
- Lead Sponsor
- Vidya Herbs P Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects having weight > 50 Kg
2.Subjects who have no evidence of any underlying disease
3.Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test.
4. Must be willing and able to give informed consent and comply with the study procedures
1Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease) requiring medical treatment
2History of
Chronic metabolic disease, Psychiatric illness,Drug abuse, smoking, abuse/addiction to alcohol, Eating disorder such as bulimia or binge eating, Endocrine abnormalities including stable thyroid disease, Cardiovascular surgery History of any major surgery
3Subjects allergic to herbal products
4Known HIV or Hepatitis B positive or any other immuno-compromised state
5Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation
6Currently participating or having participated in another clinical trial during the last 1 month prior to the beginning of this study
7.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in liver function parameters from baseline to end of treatmentTimepoint: Day 0, Day 90
- Secondary Outcome Measures
Name Time Method Changes in other Laboratory parameters and Vital SignsTimepoint: Day 0, day 90;Incidence of AE/SAEsTimepoint: Day 0, Day 90