CTRI/2021/07/034572尚未招募2/3 期
Open Labelled Clinical study to Evaluate the Effect of Draksha (Vitis Vinifera Lin) Panak in Dyslipidaemia.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- A clinical study to evaluate efficacy of Draksha (vitis vinifera Lin.) Panak in Dyslipidaemia. Parameter of efficacy will be Blood Lipid Profile Reports before and after treatment.
研究概览
简要总结
This study is open labelled Randomized comparative clinical trial to evaluate the effect of Draksha (vitis vinifera Lin.) Panak for 60 days with Pathya ahara in patients with Dyslipidaemia. The Primary outcome will be on Blood Lipid levels in patients with Dyslipidaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient of age group 20 to 50 years,irrespective of their gender, religion.
- •2.Patients with abnormal Sr. lipid levels are singly, or in the cluster of two or all three.
- •3.Irrespective of taking lipid lowering drug therapy.
- •4.Irrespective of family hidtory of Atherosclerotic Cardiovascular Disease (ASCVD), Dyslipidaemia.
- •5.Patient irrespective of known case of HTN.
排除标准
- •1.Patient with Mrudu koshta.
- •2.Patient known case of Diabetes Mellitus.
- •3.pregnant Woman.
- •4.Patient with known case of Atherosclerotic Cardiovascular Disease/ ischemic heart disease.
- •5.Patient with operated for heart blockages like PTCA or Bypass surgery.
- •Patient with known congenital heart disease.
结局指标
主要结局
A clinical study to evaluate efficacy of Draksha (vitis vinifera Lin.) Panak in Dyslipidaemia. Parameter of efficacy will be Blood Lipid Profile Reports before and after treatment.
时间窗: The drug will be given for 60 days. Patient will be assessed on 25th day, 30th day, 45th day and 60th day of the treatment.Total duration of the study will be 2 months
次要结局
- A clinical study to evaluate efficacy of Draksha (vitis vinifera Lin.) Panak in Dyslipidaemia. Parameter of efficacy will be Blood Lipid Profile Reports before and after treatment. therefore secondary outcome will relief in sign and symptoms of dyslipidaemia(The drug will be given for 60 days. Patient will be assessed on 25th day, 30th day, 45th day and 60th day of the treatment.Total duration of the study will be 2 months)
研究者
研究点 (1)
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