Randomized Trial to study the effect of lifestyle Management through Indian System of Medicine including Yoga in heart failure patients along with standard care in modern medicine

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/013605

Enrollment

100

Registered

2018-05-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Heart Failure Patients

Interventions

Intervention1: YOGA and LIFE STYLE MANAGEMENT: YOGA and LIFE STYLE MANAGEMENT THROUGH INDIAN SYSTEM OF MEDICINE ALONG WITH STANDARD CARE IN MODERN MEDICINE Control Intervention1: Standard Care in Mode

Eligibility

Inclusion criteria

Inclusion criteria: Adult (18-70 years) Male / Female patients visiting the Cardiology OPD Participant willing to give informed consent and to come for follow up Patient with left ventricular dysfunction with NYHA class I& II with EF Exercise capacity (ability to walk on level ground at own pace for 5 minutes at least, able to do household) and self care work so as to ensure reasonable exercise capacity and exclude sick patients

Exclusion criteria

Exclusion criteria: Patient already recruited for other trials. Inability to comply with the protocol or not willing to give consent. Pregnancy and lactation. Patients with NYHA class III &IV. Past 3 months h/o or planned for re-vascularisation CABG/ PTCA in next 3 months. Patient with h/o unstable angina in last three months. Other major organ dysfunction like renal dysfunction (Blood Urea >50 mg%, S.Creatinine >1.8 mg%) & hepatic dysfunction (AST/ ALT/ ALP/ Total S. Bilirubin > 3 times the upper normal limit ) With other co-morbid conditions like uncontrolled diabetes mellitus, hypertension and malignancy. Any other condition which the investigator thinks may jeopardize the study. Psychiatric disease, Participated in similar study previously ,Chronic kidney disease Active liver disease.

Design outcomes

Primary

Measure	Time frame
Primary Outcome: Quality of Life (Kansas City Cardiomyopathy Questionnaire) Timepoint: Base line and Six Months	—

Secondary

Measure	Time frame
1. Functional capacity (NYHA and 6 minute walk test) 2. Safety (compliance, drop outs) 3.Clinical Outcomes (Hospital Visits, emergency room visits, admissions, mortality, blood pressure, heart rate, body weight) 4. Cardiac function (echo-cardiography) 5. Biochemical outcomes (ST2 ,Pro NT-BNP, Inflammatory [IL-6], Oxidative stress [Super oxide dismutase] and other markers, lipids and blood sugar) Timepoint: Base line and Six Months	—

Measure

Time frame

1. Functional capacity (NYHA and 6 minute walk test) 2. Safety (compliance, drop outs) 3.Clinical Outcomes (Hospital Visits, emergency room visits, admissions, mortality, blood pressure, heart rate, body weight) 4. Cardiac function (echo-cardiography) 5. Biochemical outcomes (ST2 ,Pro NT-BNP, Inflammatory [IL-6], Oxidative stress [Super oxide dismutase] and other markers, lipids and blood sugar) Timepoint: Base line and Six Months

—

Countries

India

Contacts

Public ContactDr Sandeep Seth

A.I.I.M.S,New Delhi.

drsandeepseth@hotmail.com01126584970

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026