An Open Label, Prospective, Multicentric, Non-Comparative, Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of Cardoherb in the Management of Cardiac Insufficiency as a Cardio-Protective Ayurvedic Proprietary Medicine in Adult Subjects.

Dhathri Ayurveda Private Limited0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

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•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.

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