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 diagnosis of significant Coronary Artery Disease (CAD) with Non significant atherosclerotic plaque � 30% to�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
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 � 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 � 180/100 mm Hg. 9.Subjects with BMI 10.Subjects with Type 1 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.Subjects with abnormal Liver Function Test (LFT) with values more than 3 times the upper limit of normal. 16.Subjects with physical disability in any form leading to immobilization. 17.Subjects with Irritable bowel syndrome. 18.Subjects with clinically diagnosed bleeding piles or prolapsed or fistula (grade I or II piles). 19.Subjects with Hemorrhoids (2nd or 3rd degree). 20.Subjects with suspected inability or unwillingness to comply with the study procedures. 21.Subjects with known case of Soya food allergy 22.Subjects with suspected hypersensitivity to any of the ingredients of study medication. 23.Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 24.Suspected inability or unwillingness to comply with the study procedures. 25.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 |
|---|---|
| 1.Percentage change in Total atheroma volume (TAV) of ââ?°Â¥ 0.3% from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiographyTimepoint: 120 Days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage of population achieving change in Total atheroma volume (TAV) of ââ?°Â¥ 0.3% from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiography. 2.Determination of change in Percentage Atheroma Volume (PAV) from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiography.Timepoint: 120 days. | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Vaidya Sane Ayurvedic Lab Pvt. Ltd.
Outcome results
None listed