Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible for the study, patients must meet the following criteria: 1. Provide written informed consent. 2. Male or female patients between 25 to 65 years of age with clinical diagnosis of Chronic Heart Failure (CHF). 3. History of CHF irrespective of angioplasty and coronary artery bypass graft (CABG) on standard Treatment. 4. Stress test MET value between 3 to 7. 5. Ejection fraction between 30%-65% 6. 2D Echo done within 6months
Exclusion criteria
Exclusion criteria: 1.Female patients who are pregnant or lactating or planning to become pregnant during the study period. 2. Acute Heart Failure. 3. Patients who had acute decompensated heart failure attack in last 3 months. 4. Patients who are not on stable dose of standard treatment of chronic heart failure since last 3 months and need upward dose titration will be excluded. 5.Irritable bowel syndrome. 6.Clinically diagnosed bleeding piles or prolapsed or fistula (grade I or II piles). 7.Hemorrhoids (2nd or 3rd degree). 8.Known case of Asthma or COPD. 9.Known case of cancer. 10.Physical disability in any form leading to immobilization. 11.Uncontrolled hypertension (SBP more than 150 mm of Hg and DBP more than 90 mm of Hg). 12.Anemia (Hemoglobin less than 10 gm/dL). 13.Uncontrolled Blood sugar level (fasting below 60 mg/dL and PLBS above 250 mg/dL). 14 Abnormal thyroid function test. 15 Patients with hepatic or renal insufficiency. 16 Participation in another study within 30 days. 17 Suspected inability or unwillingness to comply with the study procedures. 18.Suspected hypersensitivity to study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Mean change from baseline in MET score â?¢Mean change from baseline in VO2max Timepoint: â?¢Mean change from baseline in MET score at the end of six weeks. â?¢Mean change from baseline in VO2max at the end of six weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Mean change from baseline in quality of life â?¢Mean change from baseline in ejection fraction â?¢Mean change from baseline in time for ischemia â?¢Mean change from baseline in double pressure product â?¢Mean change from baseline in heart rate recovery Timepoint: â?¢Improvement in quality of life assessed by QOL Questionnaire â?¢Improvement in ejection fraction assessed by using Two-Dimensional Echocardiogram (2D Echo) â?¢Improvement in time for ischemia assessed by Stress test (ST in second) â?¢Improvement in double pressure product assessed by blood pressure monitoring â?¢Improvement in heart rate recovery assessed by heart rate monitoring | — |
Countries
India
Contacts
Vaidya Sane Ayurved Lab PVT LTD (