A clinical Study to see effect and safety of Ayurveda-Based Coronary Plaque Stabilization Program in Known CAD Subjects with Chronic Heart Disorders.

Not Applicable

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

• Registration Number: CTRI/2022/06/043244
• 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: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male or female subjects between 40 to 75 years of age.

2.Subjects with Known case of CAD with Total atheroma volume more than 150 mm3.

3.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

Cohort I-IHD:

i.Stress test positive for inducible ischaemia.

ii.MET value < 7.

Cohort II-CHF:

i.Stress test negative for inducible ischaemia.

ii.MET value < 7.

Cohort III-For Asymptomatic CAD:

i.Stress test negative for inducible ischaemia.

ii.MET value > 7.

Exclusion Criteria

1.Subject with severe Calcified plaque or no plaque as detected by Coronary Computed Tomographic (CCT) angiography.

2.Subjects with history of Coronary Artery Bypass Grafting (CABG).

3.Subjects with known case of symptomatic CAD (Chest pain at Rest).

4.Subjects with recent acute coronary syndrome (within last 3 months).

5.Subjects with acute heart failure (within 24hrs).

6.Subjects with all anomalies of coronary arteries.

7.Subjects with uncontrolled hypertension with blood pressure � 180/100 mm Hg.

8.Subjects with BMI < 23 kg/m2.

9.Subjects with Type 1 Diabetes Mellitus.

10.Subjects with uncontrolled Type 2 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.Known case of CKD Sr Creatinine >1.5mg/dL

16.Subjects with abnormal Liver Function Test (LFT) with values more than 3 times the upper limit of normal.

17.Known HFrEF with LVEF <40%

18.Subjects with physical disability in any form leading to immobilization.

19.Subjects with Irritable Bowel Syndrome (IBS).

20.Subjects with clinically diagnosed bleeding piles or prolapsed fistula (Grade I or II piles).

21.Subjects with Hemorrhoids (2nd or 3rd degree).

22.Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.

23.Subjects with suspected inability or unwillingness to comply with the study procedures.

24.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.

25.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
â�¢ Mean change in Total Atheroma Volume (TAV) from baseline to end of study visit using Coronary Computed Tomographic (CCT) angiographyTimepoint: 84�±2 days

Secondary Outcome Measures

Name	Time	Method
Percent change in Abdominal girth from baseline to end of studyTimepoint: 84�±2 days;Percent change in LDL from baseline to end of studyTimepoint: 84�±2 days;Percent change in TG from baseline to end of studyTimepoint: 84�±2 days;Percent change in Weight from baseline to end of studyTimepoint: 84�±2 days