To study the effect of Ischemia Reversal Program (IRP) along with diet modification for subjects suffering Coronary Artery Disease (CAD).

Active, not recruiting

• Conditions: Atherosclerotic heart disease of native coronary artery,

• Registration Number: CTRI/2020/01/022814
• Lead Sponsor: Vaidya Sane Ayurvedic Lab Pvt Ltd

Brief Summary

This is a Multicentre, Single arm, Open label, Clinical trial to determine the Efficacy and Safety of Ischemia Reversal Program (IRP) along with diet modification as an add-on therapy to conventional treatment on plaque volume of Coronary Artery Disease (CAD) subjects.



The Primary Endpoint is

1. Percentage change in Total atheroma volume (TAV) of ≥ 0.3% from baseline to end of study visit using Intravascular

Ultrasound (IVUS) guided angiography.

The Secondary Endpoint is

1.Percentage of population achieving change in Total atheroma volume (TAV) of ≥ 0.3% from baseline to end of study

visit using Intravascular Ultrasound (IVUS) guided angiography.

2.Determination of change in Percentage Atheroma Volume (PAV) from baseline to end of study visit using

Intravascular Ultrasound (IVUS) guided angiography.



The safety will be assessed based on the frequency of Adverse Events and changes in laboratory values.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Last Update Posted: 2021-11-27

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 1.Male or female subjects between 40 to 75 years of age.
• 2.Subjects with diagnosis of significant Coronary Artery Disease (CAD) with Non significant atherosclerotic plaque ≥ 30% to≤70% in target vessel which should be of minimum of 40 mm as detected by Intravascular Ultrasound(IVUS) guided angiography.
• 3.Subjects with known case of Type 2 Diabetes Mellitus (on regular and stable medication from last 3 months).
• 4.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

Exclusion Criteria

• 1.Subject with severe Calcified plaque or no plaque as detected by Intravascular Ultrasound (IVUS) guided angiography.
• 2.Subjects with total atheroma volume of ≤ 50mm3 as detected by Intravascular Ultrasound (IVUS) guided angiography at screening visit.
• 3.Subjects with history of Coronary Artery Bypass Grafting (CABG) and Percutaneous transluminal coronary angioplasty (PTCA).
• 4.Subjects with known case of symptomatic CAD (Chest pain at Rest).
• 5.Subjects with recent acute coronary syndrome (within last 3 months).
• 6.Subjects with acute heart failure (within 24hrs).
• 7.Subjects with all anomalies of coronary arteries.
• 8.Subjects with uncontrolled hypertension with blood pressure ≥ 180/100 mm Hg. 9.Subjects with BMI < 23 kg/m2.
• 10.Subjects with Type 1 Diabetes Mellitus.
• 11.Subjects with known case of Diabetic ketoacidosis.
• 12.Subjects with known case of Active malignancy 13.Subjects with known case of Hyperthyroidism.
• 15.Subjects with abnormal Liver Function Test (LFT) with values more than 3 times the upper limit of normal.
• 16.Subjects with physical disability in any form leading to immobilization.
• 18.Subjects with clinically diagnosed bleeding piles or prolapsed or fistula (grade I or II piles).
• 19.Subjects with Hemorrhoids (2nd or 3rd degree).
• 20.Subjects with suspected inability or unwillingness to comply with the study procedures.
• 21.Subjects with known case of Soya food allergy 22.Subjects with suspected hypersensitivity to any of the ingredients of study medication.
• 23.Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
• 24.Suspected inability or unwillingness to comply with the study procedures.
• Females who are not ready to use acceptable contraceptive methods during the course of study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Percentage change in Total atheroma volume (TAV) of ≥ 0.3% from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiography	120 Days.

Secondary Outcome Measures

Name	Time	Method
1.Percentage of population achieving change in Total atheroma volume (TAV) of ≥ 0.3% from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiography.	2.Determination of change in Percentage Atheroma Volume (PAV) from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiography.

Trial Locations

Locations (2)

Aditya Birla Memorial Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Chopda Medicare & Research Centre Pvt. Ltd.; Magnum Heart Institute; 🇮🇳 Nashik, MAHARASHTRA, India

Aditya Birla Memorial Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Rajesh Badani

Principal investigator

91-9823818400

badani_rajesh@yahoo.co.in