Assessment Of Efficacy Of Amrutadi Lipicare In Dyslipidaemia-A Randomized Controlled Clinical Study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Amrutadi Lipicare may show a positive impact on the lipid profile of patients with
研究概览
简要总结
Dyslipidaemia is a metabolic disorder characterized by abnormally high or low levels of lipids (e.g., fats, triglycerides, cholesterol, phospholipids) or lipoproteins in the blood. It is a significant risk factor for the development of atherosclerotic cardiovascular diseases (ASCVD), including coronary artery disease, cerebrovascular disease, and peripheral artery disease. So, this Study intends to find out the efficacy of Amrutadi Lipicare in dyslipidaemia. The subjects are randomly selected and grouped into two groups as follows: Group-A: Amrutadi Lipicare 6 gm twice daily empty stomach with warm water at 7 AM & 5 PM and in Group B: Controlled group of Dyslipidaemia patients treated with Amalaki churna 6 gm twice daily empty stomach with warm water at 7 AM & 5 PM. Total duration of study is 2 Months.
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
- 25.00 Year(s) 至 69.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients having one or more abnormal lipid levels in their lipid profile investigation.
- •2.Individuals willing to participate in the clinical trial and provide informed consent.
- •3.Patient willing to discontinue Anti-lipidemic drug during research study.
- •4.Lipid profile ranges included for patient selection are as follows:(As per NCEP ATP 3 Guideline) Serum Cholesterol: 200-239 mg/dL and above 240 mg/dL Serum Triglyceride: between 150-499 mg/dL Serum LDL between 130-189 mg/dL Serum HDL between 10-40 mg/dL
- •BMI less than30 kg/m2.
排除标准
- •Pregnant and lactating women.
- •Patients suffering from acute or chronic major illness which may interferes the study result.
- •Patients with very high levels of cholesterol, specifically: Total Cholesterol: greater than 400 mg/dL Serum Triglyceride: greater than 500 mg/dL Serum LDL Cholesterol: greater than 190 mg/dl 4)BMI greater than 30 kg/m2.
结局指标
主要结局
Amrutadi Lipicare may show a positive impact on the lipid profile of patients with
时间窗: 2 Months
Dyslipidaemia.
时间窗: 2 Months
次要结局
- Amrutadi Lipicare may demonstrate a positive impact on the Body Mass Index (BMI) of patients with Dyslipidaemia.(2 Months)
研究者
Dr Payal Maheriya
G J Patel Institute of Ayurvedic Studies & Research