An Open Label Randomised Controlled Clinical Study to Evaluate the Efficacy of Virechana followed by Bruhat Panchamoola Kashaya in the Management of Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Virechana followed by Bruhat Panchamoola Kashaya in the management of Dyslipidemia
研究概览
简要总结
Dyslipidemia is a disorder of lipoprotein metabolism, which can include overproduction or deficiency of lipoproteins or both. The disorder can manifest as an elevation of plasma cholesterol, triglycerides, or both, or a low HDL level or all three together that contributes to the development of atherosclerosis.
The prevalence of Dyslipidemia across the nation has been reported as; 24.0% of hypercholesterolemia, 20.9% of high LDL-cholesterol, 66.9% low HDL-cholesterol and 32.1% of hypertriglyceridemia. Cardiovascular disease is the most significant complication of Dyslipidemia owing to more than 4 million deaths each year, worldwide.
The management protocol for Dyslipidemia includes lifestyle modifications, diet, exercise and administration of statins in various intensities. Statin therapy is also used in primary and secondary prevention of the disease. It is added with two other classes of medications aimed at inhibiting the absorption of cholesterol and decreasing LDL-C levels which has in turn shown to decrease cardiovascular outcomes.
Many Ayurvedic formulations have been proven to have anti-dyslipidemic activity. There remains a scope for research in this field owing to the prevalence of the disease. Therefore, Bruhat Panchamoola Kasha has been chosen as the trial drug for the present study. Triphala Kasha, a proven drug for Dyslipidemia, is taken as the control drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •Serum CHOLESTEROL (201-400mg/dL) Serum TRIGLYCERIDES (150-400mg/dL) Serum LDL (130-189mg/dL) Serum HDL (1-40mg/dL) Serum VLDL (31-100mg/dL).
排除标准
- •Subjects with uncontrolled Diabetes Mellitus with HbA1c more than 10 per cent, IDDM or Hypertension with SBP/DBP more than or equal to 160/110mmHg Subjects with any other known systemic disorder which may interfere with the study Pregnant and lactating women.
结局指标
主要结局
To evaluate the efficacy of Virechana followed by Bruhat Panchamoola Kashaya in the management of Dyslipidemia
时间窗: 0th day | 71st day
次要结局
- Lipid profile test(Before treatment - 0th day)
研究者
Dr Sai Sudha C S
JSS Ayurveda Medical College
