To evaluate the Efficacy of Punica Granatum in Promotion of Cardiovascular Health
- Conditions
- Health Condition 1: I998- Other disorder of circulatory system
- Registration Number
- CTRI/2022/03/040868
- Lead Sponsor
- CSIR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Patients who are willing to undergo for the treatment.
Age between 20 -70 years.
Pre-hypertensive patients (as per JNC VII Criteria) and impaired lipid profile.
Hypertensive patients (SBP>=140mm of Hg and/or DBP>=90mm of Hg).
Patients with FBS >150mg/dl; PPBS > 200mg/dl; RBS > 250mg/dl.
Subjects with established diagnosis of CAD requiring any procedure in next 6 months â?? angioplasty or bypass surgery or subjects with New York Heart Association (NYHA) Classification Category III and IV cardiac insufficiency, or any other clinically significant cardiovascular disease.
Subjects with Haemoglobin percentage < 9 gm% for males and <8gm% for females.
Patients suffering from major systemic illness necessitating long term treatment (R.A., PTB, malignancy etc.).
Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit)
Subject on systemic or oral steroids, oral contraceptive pills or estrogens replacement therapy.
Any other condition which the Investigator thinks may compromise the safety of the subject.
Pregnant/ lactating women.
Patients who have participated in any clinical trial during past 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Hs-CRP from 1st day i.e. baseline to 12th week. <br/ ><br>Change in functional capacity from 1st day i.e. baseline to 12th week. <br/ ><br>Change in S. Lipid profile from 1st day i.e. baseline to 12th week. <br/ ><br>Change in blood Pressure from 1st day i.e. baseline to 12th week.Timepoint: 84 days
- Secondary Outcome Measures
Name Time Method Change in FBS and HbA1c from 1st day i.e. baseline to 12th week. <br/ ><br>Change in Heart Rate from 1st day i.e. baseline to 12th week. <br/ ><br>Change in weight and BMI from 1st day i.e. baseline to 12th week. <br/ ><br>Change in SF-36 health survey score from 1st day i.e. baseline to 12th week.Timepoint: 12 weeks