CTRI/2025/01/079662尚未招募2 期
Efficacy of Badranjboya as an add-on therapy in heart failure with reduced ejection fraction: A randomized, double-blind placebo-controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome is the difference in 6 MWT
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The primary outcome is the difference in 6 MWT
时间窗: 0th 14th 28th and 42th days
次要结局
- Improvement in heart function assessed by NYHA classifications(Improvement in left ventricular ejection fraction (LVEF))
研究者
Dr Zarif Alfeeq Bin Zainurmallal
National Institute of Unani Medicine
研究点 (1)
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