An Open-Label Clinical Study to Evaluate the Efficacy and Safety of Cardorium Plus (Licensed Ayurvedic Drug) as an Adjunct to Standard Modern Medicine in Subjects with Cardiomyopathy (Heart Failure).

Cardiomyopathy, a heterogeneous group of myocardial disorders, is characterized by structural and functional abnormalities in the heart muscle that may lead to progressive heart failure, arrhythmias, or sudden cardiac death. The etiology of cardiomyopathy is multifactorial, including hypertensive, diabetic, viral, and drug-induced origins, which complicate its diagnosis and management. Hypertensive cardiomyopathy, resulting from chronic pressure overload due to systemic hypertension, induces left ventricular hypertrophy and subsequent diastolic dysfunction. Viral cardiomyopathy, often triggered by viral myocarditis, involves direct viral injury or immune-mediated damage to the myocardium. Drug-induced cardiomyopathy, on the other hand, is an increasingly recognized cause, stemming from cardiotoxic effects of chemotherapeutic agents, recreational drugs, or other pharmacological substances. Cardorium Plus, a licensed Ayurvedic formulation, is known for its cardioprotective properties, including anti-inflammatory, antioxidant, and lipid-modulating effects. By integrating Cardorium Plus as an adjunct to standard care of modern treatment. The primary objective is to evaluate the efficacy of Cardorium Plus in improving left ventricular function (LVEF %) and reducing symptoms of heart failure in subjects with Cardiomyopathy (Hypertensive, Diabetic, Viral and Drug induced). The primary outcome is Change from baseline in left ventricular ejection fraction (LVEF) after 12 Weeks, post treatment with Cardorium Plus, accessed via echocardiography and echocardiogram. The secondary outcome is change in New York Heart Association (NYHA) classification of heart failure symptoms, hs-CRP, HbA1c, lipid profile (LDL, HDL, triglycerides), CBC, liver (SGPT and SGOT), Sr. Creatinine parameters. change from baseline in vital signs, improvement in Quality of life (QoL) score using the Kansas City Cardiomyopathy Questionnaire (KCCQ), Incidence of adverse events (AEs) and serious adverse events (SAEs) during the study.