CTRI/2020/01/022814
Active, not recruiting
未知
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.
Vaidya Sane Ayurvedic Lab Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vaidya Sane Ayurvedic Lab Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 ââ?°Â¥ 30% toââ?°Â¤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 ââ?°Â¤ 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 ââ?°Â¥ 180/100 mm Hg.
- •9\.Subjects with BMI \< 23 kg/m2\.
- •10\.Subjects with Type 1 Diabetes Mellitus.
Outcomes
Primary Outcomes
Not specified
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