Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: Ischemia Reversal Program (IRP) and Reverse Diet Kit as an add on regimen to standard cardiac therapy: Ischemia Reversal Program (IRP) is a three-pronged Ayurvedic Panchakarma therapy w
Sponsors
Vaidya Sane Ayurvedic Lab Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between 40 to 75 years of age. 2. Subjects with known case of significant Coronary Artery Disease (CAD) with soft plaque as detected by Intravascular Ultrasound (IVUS) guided angiography. 3. Subjects with known case of CAD with stable dose of standard therapy for at least 3 months. 4.Subjects with BMI in the range of 26 to 30 kg/m2. 5.Subjects with known case of Type 2 Diabetes Mellitus with HbA1c value between 7% to 8% (on regular and stable medication from last 3 months). 6.Subjects with known case of controlled Hypertension with blood pressure up to 130/90 (on regular and stable medication since last 3 months). 7. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Subject with severe Calcified plaque or no plaque as detected by Intravascular Ultrasound (IVUS) guided 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 24 hrs). 6. Subjects with Irritable bowel syndrome. 7. Subjects with clinically diagnosed bleeding piles or prolapsed or fistula (grade I or II piles). 8. Subjects with Hemorrhoids (2nd or 3rd degree). 9. Subject with known case of Asthma or COPD. 10. Subjects with known case of Cancer. 11. Subjects with physical disability in any form leading to immobilization. 12. Subjects with Anemia (Hemoglobin less than 10 gm/dL). 13. Subjects with known case of Thyroid dysfunction. 14. Subjects with hepatic or renal insufficiency. 15. Subjects with suspected inability or unwillingness to comply with the study procedures. 16. Subjects with suspected hypersensitivity to any of the ingredients of study medication. 17. Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 18. Suspected inability or unwillingness to comply with the study procedures. 19. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Mean Plaque volume using IVUS guided angiographyTimepoint: Reduction in mean Plaque volume from baseline to end of study visit (120 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in maximum atheroma area in IVUS guided angiographyTimepoint: Reduction in atheroma area in IVUS guided angiography from baseline to the end of study visit (120 days);Mean change in Apo A1Timepoint: Improvement in Apo A1 from baseline to end of study visit (120 days);Mean change in Apo BTimepoint: Reduction of Apo B from baseline to end of study visit (120 days);Mean change in external elastic membrane (EEM)Timepoint: Reduction in external elastic membrane from baseline to end of study visit (120 days);Mean change in Summed difference score in Myocardial perfusion imagingTimepoint: Reduction in summed difference score in Myocardial perfusion imaging from baseline to end of study visit (120 days) | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Vaidya Sane Ayurvedic Lab Pvt. Ltd.
Outcome results
None listed