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Clinical Trials/CTRI/2020/01/022814
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Vaidya Sane Ayurvedic Lab Pvt Ltd

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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