A randomized controlled clinical study of Vachadi Vati in the management of Hyperlipidemia.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- 1. To evaluate the efficacy of Vachadi Vati in the management of Hyperlipidemia
研究概览
简要总结
Hyperlipidemia is characterized by an elevated level of serum cholesterol, serum triglyceride and low-density lipoprotein and low level of high-density lipoprotein in blood. Hyperlipidemia can be very serious if not managed. The well-known leading cause of vascular diseases is hyperlipidemia. Long term exposure to sedentary lifestyle promotes atherosclerosis and subsequently develops vascular disorders like stroke, myocardial infract, peripheral artery disease, micro vascular diseases etc. Metabolic and lifestyle disorders like Diabetes, obesity, hypothyroidism; PCOS, chronic kidney disease etc. also promote to increase lipid levels in blood. The prevalence of Hyperlipidemia is increasing all over India hence there is a need to take major steps for prevention and management of Hyperlipidemia.
In Ayurveda multiple drugs have been mentioned. Their Agnivardhak, medohar, kledaghna, kaphaghna properties helps in lowering the lipid level but also useful in samprapti bhanga of Ras-raktagat snehavriddhi. Hence in current study Vachadi Vati has been chosen to treat hyperlipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of Hyperlipidemia irrespective of gender
- •Patients with high blood lipid profile.
- •Lipid profile showing any one or more of the following criteria is considered for diagnosis of hyperlipidemia.
- •According to NCEP ATP III classification following are the levels to be selected for said project Patient having Serum Total Cholesterol Level 200-239 mg/dl Patient having Serum Triglyceride Level 150-199 mg/dl Patient having Serum LDL Cholesterol Level 130-159 mg/dl Patient having Serum HDL Cholesterol Level 20-40 mg/dl Patient having serum VLDL Cholesterol Level 40-60 mg/dl Patients having one or more of above levels will be selected for said project.
- •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).
排除标准
- •Pregnant women & lactating mother.
- •Chronic illness and infection like TB, CA and HIV infection.
- •Patient suffering with psychological disorders like anxiety, depression.
- •Patient with Respiratory Diseases Complications, Coronary Heart Disease, Hepatic or Renal Diseases etc.
- •Drug induced Hyperlipidemia.
结局指标
主要结局
1. To evaluate the efficacy of Vachadi Vati in the management of Hyperlipidemia
时间窗: 60 Days | Follow up-Patients will be screened clinically and Lipid Profile will be repeated on 30th and 60th day.
2. To evaluate the efficacy between Vachadi Vati and Tablet Rosuvastatin in the management of Hyperlipidemia.
时间窗: 60 Days | Follow up-Patients will be screened clinically and Lipid Profile will be repeated on 30th and 60th day.
次要结局
- 1. To observe the effect of Vachadi Vati on Lipid levels over the period of 60 days(2. To study in detail about Rasaraktagat snehavriddhi accordingto Ayurvedi Classics.)
研究者
Dr Snehal Chandrakant Ranzunjare
R A Podar Ayurvedic Medical College