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

Not Applicable

• Conditions: Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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.

14.Subjects with serum creatinine level � 2 mg/dL.

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.

17.Subjects with Irritable bowel syndrome.

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.

25.Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified