CTRI/2025/01/079662Not yet recruitingPhase 2
Efficacy of Badranjboya as an add-on therapy in heart failure with reduced ejection fraction: A randomized, double-blind placebo-controlled trial
National Institute of Unani Medicine1 site in 1 country30 target enrollmentStarted: March 21, 2025Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The primary outcome is the difference in 6 MWT
Study Overview
Brief Summary
Purpose: To Evaluate the Efficacy of Badranjboya as an add-on therapy in heart failure with reduced ejection fraction
Design: A randomized, double-blind placebo-controlled trial
Intervention: A test group will be given Badranjboya 5 grams per day in two divided doses, and a Placebo (Wheat flour) will be given in the same as of the test group.
Main outcomes Measures:
The Primary outcome is the difference in 6-minute walk test
Secondary outcomes:
Improvement in Heart function assessed by NYHA classification
Improvement in Left Ventricular Ejection Fraction
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
The primary outcome is the difference in 6 MWT
Time Frame: 0th 14th 28th and 42th days
Secondary Outcomes
- Improvement in heart function assessed by NYHA classifications(Improvement in left ventricular ejection fraction (LVEF))
Investigators
Dr Zarif Alfeeq Bin Zainurmallal
National Institute of Unani Medicine
Study Sites (1)
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