se of Arjuna ksheerpaka in patients who have undergone Bypass surgery

Phase 2

Conditions: Health Condition 1: I257- Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectorisHealth Condition 2: null- Post Coronary Artery Bypass Graft Surgery

Recruitment & Eligibility

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

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.

Primary Outcome Measures

Name	Time	Method
1. Assessment of improvement in left ventricular function by <br/ ><br>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 Outcome Measures

Name	Time	Method
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 Lifeby 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 eventsTimepoint: At baseline, 12 weeks and 24 weeks after intervention.