A study to evaluate the effect of AYUSH SR as adjunct to usual care for cardiac rehabilitation on biochemical, physical and psychological parameters, in adult patients who underwent Coronary Artery Bypass Graft (CABG) surgery

Phase 2

Conditions: Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Registration Number: CTRI/2023/09/057564

Lead Sponsor: Central Council for Research in Ayurvedic Science (CCRAS) Ministry of AYUSH, Government of India

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients admitted for CABG surgery

2.Male or female patient’s between 18-65 years of age.

3.Subjects who underwent CABG surgery within the last 5 days with a relatively uncomplicated perioperative period

4.Subjects ready to give informed written consent

5.Subjects willing for follow up till 3 months after the intervention.

Exclusion Criteria

1.Subjects with severe respiratory or cardiac compromise, uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease or active infection.

2. complications during CABG surgery such as prolonged requirement for mechanical ventilation, acute kidney injury, and bleeding requiring transfusion or reoperation etc that may affect the clinical outcome in patients may also be excluded in the trial

3.History or diagnosis of sleep disorder, use of any other medicines with similar effect to that of AYUSH SR or using any other herbal medicines will be excluded.

4.Subjects with history of or current neurological or psychiatric impairment, or cognitive dysfunction that could compromise data collection.

5. Patients with any concurrent hepatic disorder (defined as liver enzymes SGOT/SGPT >2 times upper normal limit) or Renal Disorders (defined as S.Creatinine >1.4mg/dl).

6.Patients with poorly controlled Hypertension ( >160/100 mm of Hg) & poorly controlled Diabetes Mellitus (HbA1c >8.0%) may be excluded

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•To evaluate the role of Ayush SR as adjunct to usual care on biochemical parameters, such as serum cortisol, serum serotonin, IL-10 and biomarkers of oxidative stress following CABG. <br/ ><br>•To evaluate the role of Ayush SR as adjunct to usual care on quality of life post CABG. <br/ ><br>Timepoint: To test the blood levels of the biochemical parameters at the following time points- 1- At baseline ( before surgery). 2- Post operative day 1 , 3- On 90th post operative day.

Secondary Outcome Measures

Name	Time	Method
•Duration of stay in hospital post CABG surgery (Baseline to day of discharge) (Baseline to day of discharge) <br/ ><br>•Change in physical activity assessed through six-minute walk test (Day 5, day of discharge, 90th day) <br/ ><br>•Change in perceived stress scale (PSS) (Baseline, day of discharge, 90th day) <br/ ><br>•Change in Pittsburgh Sleep Quality Index (PSQI(Baseline, day of discharge, 90th day) <br/ ><br>Timepoint: •Duration of stay in hospital post CABG surgery (Baseline to day of discharge) (Baseline to day of discharge) <br/ ><br>•Change in physical activity assessed through six-minute walk test (Day 5, day of discharge, 90th day) <br/ ><br>•Change in perceived stress scale (PSS) (Baseline, day of discharge, 90th day) <br/ ><br>•Change in Pittsburgh Sleep Quality Index (PSQI(Baseline, day of discharge, 90th day) <br/ ><br>