Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed and confirmed cases of stable coronary artery disease such as already Angiographically documented one two or three vessel coronary disease 2. If not Confirmation of CAD may be done by any of the following Exercise stress testing or pharmacologic stress testing or an anatomic assessment of the coronary arteries or either with coronary computed tomography angiography (CTA) or an invasive coronary angiogram as and when required 3. Willing to be a part of the study
Exclusion criteria
Exclusion criteria: 1. Patients having IHD with specific conditions like acute myocardial infarction unstable angina pectoris congenital anomalies valvular diseases hypertrophic cardiomyopathies and congestive cardiac failure 2. History of PTCA or CABG within 90 days History of Renal dysfunction (Sr creatinine 1.2 mg%) chronic kidney disease GFR less than 60 ml per min 3. History of active liver disease Patients with poorly controlled Hypertension more than 160 by 100 mm of Hg and Patients with poorly controlled Diabetes Mellitus HbA1c more than 8.0 percent 4. Active liver disease AST and ALT, total bilirubin, ALP more than 2 times upper normal limit 5. Pulmonary dysfunction COPD CVA Psychiatric illness malignancy etc. 6. Patients on prolonged more than 6 weeks medication with corticosteroids or antidepressants or anti-cholinergics etc or any other drugs that may have an influence on the outcome on the study 7. Participants who were tested COVID 19 positive through a positive RT PCR in the last 30 days 8. Participants with Post COVID 19 complications or BP fluctuations following disease 9. History of hypersensitivity towards the trial drug or any ingredient 10. History of substance abuse or alcohol intake 11. Pregnant or lactating women 12. Any other condition which the PI thinks may jeopardize the safety of the patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Canadian Cardiovascular Society Angina Grading Scale Changes in Seattle Angina Questionnaire SAQ Changes in grading of exercise Stress Test(wherever applicableTimepoint: Changes in Canadian Cardiovascular Society Angina Grading Scale baseline 30th day 60th day 90th day 120th day 150th day 180th day SAQ baseline 30th day 60th day 90th day 120th day 150th day 180th day STRESS TEST Baseline 180th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in BPTimepoint: baseline 30th day 60th day 90th day 120th day 150th day 180th day SAQ baseline 30th day 60th day 90th day 120th day 150th day 180th day ;CHANGES IN ECG FINDINGS ST SEGMENT AND T WAVETimepoint: BASELINE DAY 180TH;CHANGES IN HEALTH RELATED QUALITY OF LIFE SF 12Timepoint: baseline 30th day 60th day 90th day 120th day 150th day 180th day SAQ baseline 30th day 60th day 90th day 120th day 150th day 180th day ;CHANGES IN LABORATORY SAFETY PARAMETERS CBC LFT KFTTimepoint: BASELINE DAY 90 DAY 180;Changes in LIPID PROFILETimepoint: BASELINE DAY 180TH;Changes in the grade of Canadian Cardiovascular Society Grading scale of Angina PectorisTimepoint: baseline 30th day 60th day 90th day 120th day 150th day 180th day SAQ baseline 30th day 60th day 90th day 120th day 150th day 180th day ;Changes in the grading of Exercise stress testTimepoint: baseline 180th day;CHANGES IN THE LEVEL OF IL 6 Sr Pro BNPTimepoint: BASELINE DAY 180;INCIDENCE OF ADVERSE EVENTSTimepoint: 30th day 60th day 90th day 120th day 150th day 180th day SAQ baseline 30th day 60th day 90th day 120th day 150th day 180th day ;PROPORTION OF THE PARTICIPANTS WITH REDUCTION IN THE DOSES OF STANDARD CARE MEDICATIONS FOR CAD FROM BASELINETimepoint: BASELINE DAY 180 | — |
Countries
India
Contacts
Public ContactDr Sakshi Sharma
VMMC and Safdarjung Hospital
Outcome results
None listed