Evaluation of Comparative Efficacy of Khadir Vati Versus Atorvastatin in the Management of Dyslipidemia - A Randomized Controlled Trial
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
- To compare the efficacy of Khadir Vati and Atorvastatin on Lipid Levels – Total cholesterol, Triglyceride, LDL (Low density lipoprotein) and HDL (High density lipoprotein).
研究概览
简要总结
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a Randomized open labelled Standard controlled equivalence clinical trial. It will include a 45 days treatment period and a follow up period of 0th and 45th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to Participate with written informed consent Patient between age group 30 to 60 years of either sex Newly diagnosed cases of Dyslipidemia according to National Cholesterol Education Program and Adult Treatment Panel III (NCEP ATP III 2004) as follows TCH more than or equal to 200 mg per dL and or LDL C between 130 to 189 mg per dL and or Serum TG between 150 to 499 mg per dL and or Serum HDL C less than 40mg per Dl.
排除标准
- •Known cases of major illness like cardiovascular disorder, hepatic, & renal disorders Dyslipidemia due to consumption of drug such as glucocorticoids Subjects having MI (myocardial infarction), Angina, Stroke, TIA (transient ischemic attack), major cardiovascular surgeries in 6 months Patients already on statins or other lipid-lowering agents and blood thinner Pregnant and Lactating women.
结局指标
主要结局
To compare the efficacy of Khadir Vati and Atorvastatin on Lipid Levels – Total cholesterol, Triglyceride, LDL (Low density lipoprotein) and HDL (High density lipoprotein).
时间窗: at baseline | 45 day
次要结局
- comparison & assessment of efficacy of Khadir Vati & Atorvastatin on Lipid Levels – Total cholesterol, Triglyceride, LDL (Low density lipoprotein) & HDL (High density lipoprotein)(at baseline)
研究者
Dr Shital Gulabrao Chavan
Mahtma Gandhi Ayurved College Hospital and Research Centre salod hirapur wardha