Health Condition 1: I257- Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris Health Condition 2: null- Post Coronary Artery Bypass Graft Surgery
Conditions
Interventions
Intervention1: Arjuna Ksheerpaka with Standard Treatment of care: The active treatment will be a supplement of sachet containing concentrated Arjuna ksheerapaka extract granules and excipients. None o
Sponsors
Centre for Integrative Medicine and Research CIMR
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: a) All ambulatory patients within 5 year of CABG surgery after a review period of 3 months. b) Both Genders, c) Age between 35-70 years, d) Patients with uncomplicated peri-operative course e.g. Perioperative myocardial infarction, Infection, Bleeding, Non-healing sternum etc. e) NYHA function class I & II symptoms f) LVEF less than 50 % on 2D echocardiography continuing with standard medical therapy
Exclusion criteria
Exclusion criteria: a) Patients undergoing any other regimen apart from the prescribed conventional management. b) Patients having Lactose intolerance. c) Acute and Chronic hepatic / renal failure with or without dialysis. d) Patients with accelerated Hypertension & HbA1c >10%. e) NYHA function class III and IV symptoms. f) Hypothyroidism (Serum TSH >4.1µIU/ml). g) Liver dysfunction (serum bilirubin > 1.5 times upper limit of normal or serum transaminase > 3 times upper limit of normal). h) Patients having neurodegenerative & major psychiatric disorders. i) Patients enrolled in any other study or consuming any other investigational drug. j) Patient with ICD and CRT devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of improvement in left ventricular function by 2D echocardiography - Ejection Fraction, ventricular volumes, wall thickness, wall stress, ventricular strain, diastolic function E/E, LV massTimepoint: At baseline, 12 weeks and 24 weeks after intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac marker- NT-pro BNPTimepoint: At baseline, 12 weeks and 24 weeks after intervention.;Changes in NYHA functional classTimepoint: At baseline, 12 weeks and 24 weeks after intervention.;Health related Quality of Life by SF 36Timepoint: At baseline, 12 weeks and 24 weeks after intervention.;Major adverse cardiac and cerebrovascular events which includes Mortality, Morbidity, revascularization, stroke & myocardial infarctionTimepoint: At baseline, 12 weeks and 24 weeks after intervention.;Plasma Cytokine (Interleukin-6, Interleukin-10 )Timepoint: At baseline, 12 weeks and 24 weeks after intervention.;Recurrence of hospitalisation events Timepoint: At baseline, 12 weeks and 24 weeks after intervention. | — |
Countries
India
Contacts
Public ContactGautam Sharma
All India Institute of Medical Sciences (AIIMS)
Outcome results
None listed