CLINICAL EVALUATION OF ARJUN KSHEERA PAK SPRAY DRIED POWDER & MAKARDHWAJ VATI AS AN ADJUNCT TO STANDARD THERAPY IN HEART FAILURE WITH REDUCED LEFT VENTRICULAR EJECTION FRACTION
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To help relief in symptoms of HFrEF
研究概览
简要总结
This open-label, two-arm randomized controlled trial aims to evaluate the efficacy of Arjun Ksheera Pak spray-dried powder and Makardhwaj Vati as adjuncts to standard therapy in Heart Failure with Reduced Ejection Fraction (HFrEF). Thirty patients aged 30–65 years with classical features of HFrEF will be randomly selected from the OPD and IPD of the Kayachikitsa Department, Quadra Institute of Ayurveda. Participants will be divided into two groups, one receiving conventional treatment and the other receiving conventional plus interventional therapy. The study duration for each patient will be 56 days, and the total study period is 18 months. Assessment will be based on subjective and objective parameters, and the collected data will be statistically analyzed to evaluate clinical efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •2D echocardiography: Effective ejection fraction between 20% = 40% due to any cardiac pathology.
- •Coronary Artery Disease
- •Cardiomyopathy
- •Age group: 30 years to 65 years.
排除标准
- •Pregnancy and lactating mothers
- •Significantly elevated Troponin level
- •Valvular Heart disease
- •Congenital Heart disease
- •Within one week of post Coronary artery bypass graft surgery.
- •Decompensated Heart Failure.
结局指标
主要结局
To help relief in symptoms of HFrEF
时间窗: Follow ups were scheduled at the 28th day first follow up and 56th day second follow up after initiation of the trial and outcome will be assessed at 56th day
次要结局
- Provide a alternative & safe treatment for HFrEF(18 Months)
研究者
Amaan Siddiqui
Quadra Institute of Ayurveda and Hospital