A clinical study to evaluate the safety of Puremeric in Healthy volunteers

Not yet recruiting

• Conditions: Subjects with normal Hematology and Biochemical Parameters

• Registration Number: CTRI/2019/10/021611
• Lead Sponsor: Vidya Herbs P Ltd

Brief Summary

Thisis an open label, single arm, prospective clinical study. Healthy subjects meetingall inclusion and no exclusion criteria, after signing a written informedconsent will be enrolled in the study. After passing the eligibility criteria,subjects will receive Puremeric(standardized extract from *Curcuma longa*),500 mg orally, twice a day for 90 days. The subject will arrive at the studysite in a fasted state and blood samples will be collected for laboratoryassessment. The study will be conducted in 2 visits over a period of 90 days.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-07-10
• Study Start: 2019-10-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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.
• Must be willing and able to give informed consent and comply with the study procedures.

Exclusion Criteria

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 subject’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 treatment	Day 0, Day 90

Secondary Outcome Measures

Name	Time	Method
Changes in other Laboratory parameters and Vital Signs	Day 0, day 90
Incidence of AE/SAEs	Day 0, Day 90

Trial Locations

Locations (1)

Anand Multi Specialty Hospital; 🇮🇳 Vadodara, GUJARAT, India

Anand Multi Specialty Hospital

🇮🇳Vadodara, GUJARAT, India

Dr Prithviraj Puwar

Principal investigator

drprithvi82@gmail.com