A plant based Ayurvedic medicine used for the prevention and management of various risk factors responsible for occurrence of Coronary Heart Disease.

Phase 3

Recruiting

• Conditions: Coronary Heart Disease

• Registration Number: CTRI/2015/01/005397
• Lead Sponsor: Department of Science Technology

Brief Summary

The test formulation has shownanti-atherosclerotic, anti-inflammatory and anti-obesity activity when given todiagnosed CHD patients. Further, it has shown HDL-c enhancing and triglyceridesreducing effects. When the effect of test formulation assessed on lipidprofile, inflammatory markers, endothelin, PAI, tPAI including brachial arterythickening, has revealed cardioprotective potentials. It improved the sleep and mental performanceof CHD patients also. The test formulation is safe and can be given for longertime

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-01
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Diagnosed cases of CHD consenting to participate in clinical drug trial program were included in the study.
• These CHD patient showing dyslipidemia, atherosclerotic, ischemic changes, elevated homocysteine and inflammatory markers, concentration with certain psychological complaints mainly sleep disturbances were treated with test formulation.
• The diagnosis of CHD patients were done on the basis of clinical as well as laboratory findings.

Exclusion Criteria

Patients suffering from chronic illness like T.B., Rheumatoid arthritis, diagnosed IHD cases; Type-1 diabetic patients; Evidence of hypo or hyperthyroidism; Age above 75 years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The test formulation has shown Cardio-protective property through its anti-atherosclerotic, anti-inflammatory, anti-obesity activity	Parameters measured at baseline (initial), 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
The test formulation has shown reduction in anxiety level as well as improved sleep pattern among CHD patients	Parameters measured at baseline (initial), 3 months and 6 months

Trial Locations

Locations (1)

Interdisciplinary School of Indian System of Medicine; 🇮🇳 Kancheepuram, TAMIL NADU, India

Interdisciplinary School of Indian System of Medicine

🇮🇳Kancheepuram, TAMIL NADU, India

Prof G P Dubey

Principal investigator

9450963942

gpdubey13@gmail.com