Clinical study to verify the efficacy of Cardoherb Tablet for Cardiac Insufficiency in Adults.
- Conditions
- Health Condition 1: I509- Heart failure, unspecified
- Registration Number
- CTRI/2016/04/006862
- Lead Sponsor
- Dhathri Ayurveda Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Echocardiogram: Ejection Fraction (EF) of 50% at end of study. <br/ ><br>2.6 Minute Walk Test: Improvement by 50 metres at the end of the study. <br/ ><br>3.Borg Scale: Dyspnea: Improvement by 4 scores at the end of the study. <br/ ><br>4.Borg Scale: Fatigue: Improvement by 4 scores at the end of the study. <br/ ><br>5.Quality of Life Questionnaire for Cardiac Insufficiency: Reduction of 10 scores at end of study. <br/ ><br>Timepoint: 1.Echocardiogram: At V0 (Week 0), V3 (6 Weeks), V5 (12 Weeks). <br/ ><br>2.6 Minute Walk Test: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) <br/ ><br>3.Borg Scale: Dyspnea: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) <br/ ><br>4.Borg Scale: Fatigue: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) <br/ ><br>5.Quality of Life Questionnaire for Cardiac Insufficiency: At V1 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Echocardiogram Ejection Fraction (EF) 40-49% at end of study. <br/ ><br>2.6 Minute Walk Test: Improvement by 30-49 metres at the end of the study. <br/ ><br>3.Borg Scale: Dyspnea: Improvement by 2 or 3 scores at the end of the study. <br/ ><br>4.Borg Scale: Fatigue: Improvement by 2 or 3 scores at the end of the study. <br/ ><br>5.Quality of Life Questionnaire for Cardiac Insufficiency: Reduction of 5-9 scores at end of study. <br/ ><br>Timepoint: 1.Echocardiogram: At V0 (Week 0), V3 (6 Weeks), V5(12 Weeks). <br/ ><br>2.6 Minute Walk Test: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) <br/ ><br>3.Borg Scale: Dyspnea: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) <br/ ><br>4.Borg Scale: Fatigue: At V0 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) <br/ ><br>5.Quality of Life Questionnaire for Cardiac Insufficiency: At V1 (Week 0),V2 (3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) <br/ ><br>