An open clinical trial to evaluate the efficacy ofVatsakadi Vati in management of hyperlipidemia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Study to determine the effectiveness of Vatsakadi Vati in the dose of 500mg twice a day to maintain normal lipid profile level.
研究概览
简要总结
The aim of study is toevaluate the clinical efficacy of Vatsakadi Vati with koshna jala in managementof Hyperlipidemia (Medovriddhi). To study the details of Vatsakadi Vati.To study in detailabout Medovriddhi according to Ayurvedic classics. To study in detail about Hyperlipidaemia according to modern medicine. The trial will be conductedon 50 patients showing anyone or more parameters of lipid profile i.e.,serum Cholesterol, serum Triglycerides, serum HDL, serum LDL, and serum VLDL, the range for the lipid profile will be decidedas per the American Journal of Lifestyle Medicine. Lipid profile will bechecked on the day patient enrollment. Medicine will be given for 60 days, atthe interval of 30 days patients will be assess the effect of therapy onobjective parameters. After 60 days of trial collected data of objectiveparameters will be statistically assess and conclusion will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient irrespective of age, sex, religion etc.of Hyperlipidemia.
- •2.Patients with high blood lipid profile.Lipid profile showing any one or more of the following criteria was considered diagnostic of hyperlipidemia.
- •3.Patients with controlled Type 2 diabetes mellitus and hypertensive patients with blood pressure within the normal limits.
- •4.Obese Hyperlipidemic and Non-Obese hyperlipidemic Patients (BMI-18.50 to 40.00 kg/m2 as per New Updated WHO classification of BMI of 2004).
- •5.Patient having Serum Total Cholesterol Level >200mg/dl.
- •6.Patient having Serum LDL Cholesterol Level >130mg/dl 7.Patient having serum VLDL Cholesterol Level >40mg/dl.
- •8.Patient having Serum HDL Cholesterol Level<40mg/dl.
- •9.Patient having Serum Triglyceride Level >150mg/dl.
排除标准
- •1.Patients having a history of untreated thyroid disorder.
- •2.Pregnant women & lactating mother.
- •3.Chronic illness and infection like TB, CA and HIV infection.
- •4.Patient is suffering with psychological disorders like anxiety, depression.
- •5.Patient with Respiratory Diseases Complications, Coronary Heart Disease, Hepatic or Renal Disease etc.
- •6.Drug induced Hyperlipidemia.
结局指标
主要结局
1.Study to determine the effectiveness of Vatsakadi Vati in the dose of 500mg twice a day to maintain normal lipid profile level.
时间窗: 30th day,60th day
次要结局
- 1.To study in detail about Medovriddhi according to Ayurvedic classics.(2.To study in detail about Hyperlipidemia according to modern medicine.)