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

Recruiting

• Conditions: Atherosclerotic heart disease of native coronary artery. Ayurveda Condition: HRUDROGA-UPADRAVAH,

• Registration Number: CTRI/2022/06/043244
• Lead Sponsor: Vaidya Sane Ayurvedic Lab Pvt Ltd

Brief Summary

This study is a multicentre, single arm, open label, clinical study. Subjects will be assigned to following treatment.

**Cohort I-IHD:** IRP(Panchakarma 21 sittings**) +** Reverse Diet Kit

2.      **Cohort II-CHF:**HFRT(Panchakarma 21 sittings**)  +** Reverse Diet Kit

3.      **Cohort III-For Asymptomatic CAD:** PSL(Panchakarma 21 sittings**) +** Reverse Diet Kit

There will be twice-a-week sitting of treatment for 10 weeks i.e.20 sittings and once-a-week sitting of treatment at week 11 i.e. (total 21 sittings) and a follow-up visit at week 4/day 30±2 , week 8/day 60±2 and end of study visit at week 12/90±2. Conventional treatment and reverse diet kit will be continued throughout the study till the end of study visit.

Primary endpoint

- Mean change in Total Atheroma Volume (TAV) from baseline to end of study visit using Coronary Computed Tomographic (CCT) angiography

Seconday endpoint

- Percent change in Weight  from baseline to end of study

- Percent change in Abdominal girth from baseline to end of study

- Percent change in LDL  from baseline to end of study

- Percent change in TG from baseline to end of study

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-08
• Study Start: 2022-06-15

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 300

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.
• Cohort III-For Asymptomatic CAD: i.Stress test negative for inducible ischaemia.

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.
• 13.Subjects with known case of Hyperthyroidism.
• 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).
• 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.
• 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
• Mean change in Total Atheroma Volume (TAV) from baseline to end of study visit using Coronary Computed Tomographic (CCT) angiography	84±2 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vaidya Sane’s Ayurvedic Education and Agricultural Research Trust’s MIPC; 🇮🇳 Thane, MAHARASHTRA, India

Vaidya Sane’s Ayurvedic Education and Agricultural Research Trust’s MIPC

🇮🇳Thane, MAHARASHTRA, India

Dr Jagdish Hiemath

Principal investigator

9822022441

drjagdishhiremath@gmail.com