To check the effectiveness of Cardorium Plus on Patients with Heart Failure.

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). - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/081955

Enrollment

Registered

2025-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I427- Cardiomyopathy due to drug and external agent

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1) Participants of either sex aged 18 to 65 years. 2) Participants diagnosed with type 2 diabetes for at least 5 years. 3) Participants with clinical and echocardiographic diagnosis of diabetic cardiomyopathy with left ventricular ejection fraction (LVEF) less than 45%. 4) Participants with BMI between 18 and 35 kg/m². 5) Participants with HbA1c levels between 6.5 and 12 at screening. 6) Stable medication for diabetes and heart failure for at least 3 months prior to enrolment. 7) Agrees to not participate in any other clinical trials during the course of this trial. 8) Willing to participate in the study and provide informed Consent.

Exclusion criteria

Exclusion criteria: 1) History of significant coronary artery disease, recent myocardial infarction, or coronary revascularization within 6 months. 2) Uncontrolled hypertension or heart failure requiring hospitalization in the past 6 months. 3) Individuals with known allergies to any component of the study products. 4) Subjects with severe liver or kidney disease. 5) Breastfeeding and pregnant women or women planning for a pregnancy. 6) Participation in another investigational drug trial within the last 30 days. 7) Unwillingness to comply with study procedures

Design outcomes

Primary

Measure	Time frame
a) Change from baseline in left ventricular ejection fraction (LVEF) after 12 Weeks, post treatment with Cardorium Plus, accessed via echocardiography and echocardiogram.Timepoint: Day 1 to Day 90	—

Secondary

Measure	Time frame
a) Change in New York Heart Association (NYHA) classification of heart failure symptoms. b) Changes in serum levels of hs-CRP from baseline. c) Changes in serum levels of HbA1c, and lipid profile (LDL, HDL, triglycerides). d) Change from baseline in haematological (CBC) parameters, liver (SGPT and SGOT) and kidney function (Sr. Creatinine) parameters. e) Change from baseline in vital signs (pulse rate, respiratory rate, blood pressure, and body temperature). f) Improvement in Quality of Life (QoL) score using KCCQ. g) Incidence of adverse events (AEs) and serious adverse events (SAEs) during the study.Timepoint: Day 1 to Day 90	—

Measure

Time frame

a) Change in New York Heart Association (NYHA) classification of heart failure symptoms. b) Changes in serum levels of hs-CRP from baseline. c) Changes in serum levels of HbA1c, and lipid profile (LDL, HDL, triglycerides). d) Change from baseline in haematological (CBC) parameters, liver (SGPT and SGOT) and kidney function (Sr. Creatinine) parameters. e) Change from baseline in vital signs (pulse rate, respiratory rate, blood pressure, and body temperature). f) Improvement in Quality of Life (QoL) score using KCCQ. g) Incidence of adverse events (AEs) and serious adverse events (SAEs) during the study.Timepoint: Day 1 to Day 90

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Countries

India

Contacts

Public ContactMr Manik Chaudhuri

Xplora Clinical Research Services Pvt. Ltd.

hasan@xplorahealth.com9886012598

Outcome results