Use of Arjuna ksheerpaka in patients who have undergone Bypass surgery

Phase 2

Completed

• Conditions: Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, Post Coronary Artery Bypass Graft Surgery,

• Registration Number: CTRI/2019/10/021710
• Lead Sponsor: Centre for Integrative Medicine and Research CIMR

Brief Summary

**Aim of the Study** This program aims at optimizing to  facilitate better clinical outcome and quality of life through use of *Terminalia Arjuna Ksheerpaka*  and facilitating better long-term adaptation, alleviating inflammation and better cardiac functioning in  Post CABG surgery through a study program run by specially trained team of people, including doctors, nurses etc.**.**

**Method of study**

This program adheres to evidence-based therapies that have been validated in well-conducted scientific studies. Patient information will be prospectively collected at baseline, 12 weeks and  at 24 weeks and will be well documented. The  programme will closely monitor the patients  with compliance to their  recommendations, their need for hospital visits, admissions and other outcomes . Advice and reminders will be given to improve compliance with drug therapy. patients will have to undergo the following tests:

o   Echocardiography (ECHO)

o   6 minute walk test.

o   A Questionnaire to assess improvement in quality of life called SF 36

o   Blood tests for some biochemical markers.

The trial will be a double-blinded study, where the participants and investigators will be blinded throughout the study and those involved in administering interventions, data entry will be blinded to group assignments.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-18
• Last Update Posted: 2024-08-03

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Assessment of improvement in left ventricular function by	At baseline, 12 weeks and 24 weeks after intervention.
2D echocardiography - Ejection Fraction, ventricular volumes, wall thickness, wall stress, ventricular strain, diastolic function E/E, LV mass	At baseline, 12 weeks and 24 weeks after intervention.

Secondary Outcome Measures

Name	Time	Method
Changes in NYHA functional class	At baseline, 12 weeks and 24 weeks after intervention.
Cardiac marker- NT-pro BNP	At baseline, 12 weeks and 24 weeks after intervention.
Major adverse cardiac and cerebrovascular events which includes Mortality, Morbidity, revascularization, stroke & myocardial infarction	At baseline, 12 weeks and 24 weeks after intervention.
Plasma Cytokine (Interleukin-6, Interleukin-10 )	At baseline, 12 weeks and 24 weeks after intervention.
Health related Quality of Lifeby SF 36	At baseline, 12 weeks and 24 weeks after intervention.
Recurrence of hospitalisation events	At baseline, 12 weeks and 24 weeks after intervention.

Trial Locations

Locations (1)

All India Institute of Medical Sciences (AIIMS); 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences (AIIMS)

🇮🇳South, DELHI, India

Gautam Sharma

Principal investigator

01126549326

drsharmagautam@gmail.com