A randomized controlled clinical study of karanjadi vati and rosuvastatin tablet in the management of medovridhhi with special reference to hyperlipidaemia.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- value of LDL and signs and symptoms of hyperlipidaemia (Medovridhhi).
研究概览
简要总结
This is a randomized controlled open labelled parallel group clinical trial comparing the safety and efficaccy of karanjadi vati and rosuvastatin tablet.
Null hypothesis (H0): Karanjadi Vati and Rosuvastatin Tablet are equally effective in the management of Medovriddhi W.S.R. to Hyperlipidaemia.
Alternative hypothesis (H1): Karanjadi Vati and Rosuvastatin Tablet are not equally effective in the management of Medovriddhi w.s.r. to hyperlipidaemia.
In patient having multiple (+2) risk factor with 10 year risk of ≤10% & 10%-20% whose LDL cholesterol goals not achieve (≥160mg/dl & ≥130mg/dl respectively) after TLC Then in drug therapy, Will Karanjadi Vati 500 mg twice a day after food with koshna Jala and Rosuvastatin tablet 10mg once a day at bed time daily for 6 weeks are equally effective in the management of Medovriddhi with special reference to Hyperlipidaemia ?
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient having Serum LDL Cholesterol Level above 190mg/dl.
- •According to NCEP ATP III, Patient having multiple (+2) risk factor with 10 year risk of 10% of CHD whose LDL Cholesterol goals not achieve (≥160mg/dl) after 12 weeks Therapeutic lifestyle changes (TLC).
- •According to NCEP ATP III, Patient having multiple (+2) risk factor with 10 year risk of 10% to 20% of CHD whose LDL Cholesterol goals not achieve (≥130mg/dl) after 12 weeks Therapeutic lifestyle changes (TLC).
排除标准
- •Patient with Multiple (+2) risk factor with 10 year risk 10% of CHD, who achieve the goal of LDL Cholesterol (≤160mg/dl) after TLC therapy.
- •Patient with Multiple (+2) risk factor with 10 year risk 10% to 20% of CHD, who achieve the goal of LDL Cholesterol (≤130mg/dl) after TLC therapy.
- •Pregnant women and lactating mothers.
- •Patients having history of Renal Disease, Liver Disease.
- •Patients having Recently 3 month history of Heart Failure or Stroke.
- •Patients having disorders like Carcinoma etc.
- •anywhere in the body.
结局指标
主要结局
value of LDL and signs and symptoms of hyperlipidaemia (Medovridhhi).
时间窗: 3 year
次要结局
- SAFETY AND EFFICACY OF KARANJADI VATI AND ROSUVASTATIN TABLET(3 years)