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

A randomized placebo control 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) - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057564

Enrollment

220

Registered

2023-09-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
•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. •To evaluate the role of Ayush SR as adjunct to usual care on quality of life post CABG. 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.	—

Measure

Time frame

•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. •To evaluate the role of Ayush SR as adjunct to usual care on quality of life post CABG. 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.

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Secondary

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

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDr Manoj Kumar Sahu

AIIMS New Delhi

drmanojsahu@gmail.com9911088705

Outcome results