Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: Cardoherb Tablet: The investigational product is a Cardio-protective Ayurvedic Proprietary Medicine
Dosage: Oral, 2 tablets BID (twice daily) for 12 weeks.
Control Intervention1: Not
Sponsors
Dhathri Ayurveda Private Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male and female subjects between the ages of 21 and 50 years (both ages inclusive) diagnosed with cardiac insufficiency in the last 1year. 2. Subjects with New York Heart Association classification of I or II. 3. Subjects with American Cardiology College/American heart Association classification of Stage A and B. 4. Echocardiogram Ejection Fraction: 35-45% at screening. 5. 6 Minute Walk Test: Total of 300-500 metres at screening. 6. A minimum of one cardiovascular incident requiring medical attention or hospitalisation (less than 7 days), within 1 year prior to enrolment.
Exclusion criteria
Exclusion criteria: 1. Subjects with known or suspected allergies/hypersensitivities to herbal or Ayurvedic medicines. 2. Subjects with history of chronic systolic heart failure of ischemic or non-ischemic etiology at least 1 year prior to enrolment. 3. Subjects who have suffered a myocardial infarction, had a cardiac surgery upto 3 years prior to enrolment. 4. Subjects who have suffered from uncontrolled arrhythmia, stroke, renal or hepatic impairment, heart failure due to pulmonary disease at least 1 year prior to enrolment. 5. Subjects with untreated hypertension or diabetes mellitus for 6 months prior to enrolment. 6. Subjects with severe anaemia, thrombocytopenia and other haemophilic conditions that could contribute to increased cardiovascular incidents. 7. Subjects with pulmonary arterial hypertension, myasthenia gravis or other autoimmune diseases. 8. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 9. Subjects who are known/reported to be pregnant, lactating, planning a pregnancy or unwilling to practice double barrier contraceptive. 10. Subjects who in the opinion of the investigator are deemed unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Echocardiogram: Ejection Fraction (EF) of 50% at end of study. 2. 6 Minute Walk Test: Improvement by 50 metres at the end of the study. 3. Borg Scale: Dyspnea: Improvement by 4 scores at the end of the study. 4. Borg Scale: Fatigue: Improvement by 4 scores at the end of the study. 5. Quality of Life Questionnaire for Cardiac Insufficiency: Reduction of 10 scores at end of study. Timepoint: 1. Echocardiogram: At V0 (Week 0), V3 (6 Weeks), V5 (12 Weeks). 2. 6 Minute Walk Test: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) 3. Borg Scale: Dyspnea: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) 4. Borg Scale: Fatigue: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) 5. Quality of Life Questionnaire for Cardiac Insufficiency: At V1 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Echocardiogram Ejection Fraction (EF) 40-49% at end of study. 2. 6 Minute Walk Test: Improvement by 30-49 metres at the end of the study. 3. Borg Scale: Dyspnea: Improvement by 2 or 3 scores at the end of the study. 4. Borg Scale: Fatigue: Improvement by 2 or 3 scores at the end of the study. 5. Quality of Life Questionnaire for Cardiac Insufficiency: Reduction of 5-9 scores at end of study. Timepoint: 1. Echocardiogram: At V0 (Week 0), V3 (6 Weeks), V5(12 Weeks). 2. 6 Minute Walk Test: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) 3. Borg Scale: Dyspnea: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) 4. Borg Scale: Fatigue: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) 5. Quality of Life Questionnaire for Cardiac Insufficiency: At V1 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) | — |
Countries
India
Contacts
Public ContactDr VTSriraam
Aurous HealthCare
Outcome results
None listed