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Efficacy of Unani formulation in heart failure

Efficacy of Badranjboya as an add-on therapy in heart failure with reduced ejection fraction: A randomized, double-blind placebo-controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079662
Enrollment
30
Registered
2025-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: I501- Left ventricular failure, unspecified

Interventions

Intervention1: Badranjboya (Melissa officinallis): Badranjboya will be powdered finely and fill in 833mg capsules Each patient will be given 5gm of the test drug per day in two divided doses with wate

Sponsors

National Institute of Unani Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants must have evidence of reduced left ventricular ejection fraction less than 50% and more than 30%. Age 40 to 80 years, all genders Voluntary participation and signing the informed consent. Course of disease 3 months and above, stable condition in recent 1 month or receiving routine treatment with stable doses more than 1 month Stage II and III Heart failure according to the New York Heart Association Classification

Exclusion criteria

Exclusion criteria: Acute coronary syndrome occurred in the past 1 month Plan to have cardiac surgery during the trial Patients with History of cardiogenic shock acute myocarditis uncontrollable malignant arrhythmia hypertrophic obstructive cardiomyopathy pulmonary embolism or severe valvular disease requiring surgery Participants with significant comorbidities such as renal dysfunction advanced cancer or terminal illness Uncontrolled hypertension with systolic blood pressure 160 mmHg and above diastolic blood pressure 100 mmHg and above or hypotension less than 90/50 mmHg With the History of kidney dysfunction eGFR 59 ml per minute per 1.73 square meters or less or active liver disease or AST ALT 3 times and above the upper limit of normal Severe chronic obstructive pulmonary disease Psychiatric patients or patients with a history of depression alcohol or drug abuse Pregnant women or breast feeding women or those who are trying to get pregnant during the trial Participate in other clinical studies 3 months before this trial Diabetic patients with HbA1c more than 8% Inability to comply with study

Design outcomes

Primary

MeasureTime frame
The primary outcome is the difference in 6 MWTTimepoint: 0th 14th 28th and 42th days

Secondary

MeasureTime frame
Improvement in heart function assessed by NYHA classifications Improvement in left ventricular ejection fraction (LVEF)Timepoint: 0th 14th 28th and 42th days

Countries

India

Contacts

Public ContactDr Muzafar Din Ahmad Bhat

National Institute of Unani Medicine

drmuzaffar79@gmail.com9590366192

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026