To evaluate the Efficacy of Punica Granatum in Promotion of Cardiovascular Health

A Clinical Study to evaluate the efficacy of Punica Granatum in Promotion of Cardiovascular Health

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/040868

Enrollment

100

Registered

2022-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I998- Other disorder of circulatory system

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 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.

Design outcomes

Primary

Measure	Time frame
Change in Hs-CRP from 1st day i.e. baseline to 12th week. Change in functional capacity from 1st day i.e. baseline to 12th week. Change in S. Lipid profile from 1st day i.e. baseline to 12th week. Change in blood Pressure from 1st day i.e. baseline to 12th week.Timepoint: 84 days	—

Secondary

Measure	Time frame
Change in FBS and HbA1c from 1st day i.e. baseline to 12th week. Change in Heart Rate from 1st day i.e. baseline to 12th week. Change in weight and BMI from 1st day i.e. baseline to 12th week. Change in SF-36 health survey score from 1st day i.e. baseline to 12th week.Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Vijay Chaudhary

Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P.

drvijaychaudhary@gmail.com9418130228

Outcome results