Health Condition 1: I259- Chronic ischemic heart disease, unspecified
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences (CCRAS) (Ministry of AYUSH Govt. of India)
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex aged 35-75 years 2.Subjects diagnosed with stable coronary artery disease (CAD) having GLS value poor than -6 to -16 or positive stress test.(Age more than 70year 6 min walk test may conducted instead of Stress Test) 3.Patients willing to participate in the study for 30months.
Exclusion criteria
Exclusion criteria: 1. Subjects with history of Coronary Artery Bypass Grafting (CABG) and percutaneous trans luminal coronary angioplasty (PTCA) with in the last 1year. 2. Subjects with symptomatic CAD (Chest pain at Rest); 3. Subjects with recent acute coronary syndrome (within last 1 months); 4. Subjects with congestive cardiac failure; 5. Subjects with anomalies of coronary arteries, valvular heart disease, cardiac arrhythmias; 6. Subjects with uncontrolled hypertension (BP = 180/100 mm Hg); 7. Subjects with history of CVA/Stroke (within six months) 8. Subjects with history of coagulation disorders 9.Subjects with History of uncontrolled Diabetes Mellitus with HbA1c = 10 10.History of Pulmonary dysfunction, psychiatric illness, HIV infection or any other comorbidities 11. Subjects with BMI = 35 kg/m2 12. Subjects with history of active malignancy; 13.Subjects with Serum TSH =10µIU/ml with or without medication. 14.Subjects with serum creatinine level >1.45mg/dL, chronic kidney disease (GFR 15. Subjects with abnormal Liver Function Test (LFT) with values more than two times the upper limit of normal; 16. Subjects on corticosteroids, immunosuppressive drugs or any other medication which from the investigator’s viewpoint may not be suitable for the study participation; 17. Subject with history of chain smoking, alcohol or substance abuse 18. Subjects with suspected hypersensitivity to any of the ingredients of study medication; 19. Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent; 20. Female subjects who are pregnant or lactating or planning to conceive during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study; 21. Any condition that the investigator thinks may jeopardise the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in the Global Longitudinal Strain assessed through 2D speckle tracking echocardiography in subjects with coronary artery disease (CAD) 2.Changes in LV mass, End-diastolic volume (EDV), Stroke volume (SV) assessed through 2D speckle tracking echocardiography in subjects with CAD . Timepoint: day 0, 90 and 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the Seattle Angina Questionnaire score (day 0, 30, 60, 90, 120, 150 and 180). 2. Change in the findings of exercise Stress Test (day 0 and 180) 3. Changes in cardiac risk markers like Apo A1 and B levels (day 0, 90 and 180) 4. Changes in LDL and HDL lipoprotein levels (day 0, 90 and 180). 5. Change in the Serum Pro-BNP (B-type natriuretic peptide) levels (day 0, 90 and 180) 6. Changes in the BMI and abdominal circumference (day 0, 90, and 180). 7. Changes in Quality-of-life score assessed by SF-12 questionnaire (day 0, 90, and 180). 8. Need of rescue medications for CAD 9. Incidence of Adverse events 10. Change in safety parameters (CBC, LFT, KFT, FBS, HbA1c, urine routine and microscopic examination, serum and urine heavy metals levels, USG whole abdomen, ECG) (day 0, 90, and 180). Timepoint: day 0, 90 and 180 | — |
Countries
India
Contacts
Public ContactDr Rohit Madhav Sane
Vaidya Sane Ayurved Lab Ltd.Thane
Outcome results
None listed