A Randomised Control Clinical Trial To Evaluate The Effect Of Pippali Churna In Dyslipidemia
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary outcome: Pippali churna can make positive impact on Dyslipidemia.
研究概览
简要总结
Dyslipidemia is a group of plasma lipid and lipoprotein abnormality that is metabolically associated, and it is categorized by low HDL-C and increased LDL-C, TGs, and total cholesterol (TC) levels. Dyslipidemia is one of the commonest presentation and major cause for various lifestyle disorders like cardiovascular diseases, pancreatitis, fatty liver, and many other diseases. In India, there has been an alarming increase in the prevalence of CVD over the past two decades that accounts for 24% of all deaths among adults aged 25–69 years. Prevalence of Dyslipidemia according to Indian Council of Medical Research (ICMR) Integrated Disease Surveillance varies from 10-15% in rural to 25-30% in urban populations.Worldwide, these diseases are now one of the most common causes of death. Dyslipidemia accounts for about 4.40 million global death and 98.62 million disabilities in 2019, which causes a big burden to medical system.*.*†So, this Study intends to find out the efficacy of pippali churna in dyslipidemia.One study in rats has been conducted in pippali with respect to Hyperlipidemia. That is “Effect of piperine in the regulation of obesity-induced dyslipidemia in high-fat Diet rats and the results was positive with significant reduction in total cholesterol and LDL and improvement in HDL level. But There is no clinical study has been done in Pippali churna with respect to Dyslipidemia till now in human subjects.
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
- 25.00 Year(s) 至 69.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Subjects willing to give written consent and anticipated ability to attend the scheduled visits.
- •â€¢ Subjects those who have cholesterol levels at risk (Borderline High) selected for the study.
- •Total Cholesterol: 200-239mg/dl, LDL Cholesterol: 100-159mg/dl, HDL Cholesterol: 40-59mg/dl male ,50-59mg/dl female Triglycerides : 150-199mg/dl.
排除标准
- •ï¶ Subjects those who have cholesterol levels at Dangerous not selected for the study.
- •Total Cholesterol 240mg/dl and Higher ,LDL Cholesterol 160 mg/dl Higher HDL Cholesterol lees than40 mg/dl males, Less than 50mg/dl female Triglyceride-200 mg/ dl and Higher Subjects with any other acute or chronic systemic illness or infection.
- •Dyslipidemia associated with Obesity or Diabetes.
- •Pitta predominant Prakruti subjects.
- •Pregnant and Lactating women.
- •Subjects taking anti-cholesterol drugs(Both Ayurvedic and modern drugs) Known cases of Acid Peptic Disorder.
结局指标
主要结局
Primary outcome: Pippali churna can make positive impact on Dyslipidemia.
时间窗: 90 DAYS
次要结局
- Pippali Churna can make positive impact on weight & BMI of the participants(90 DAYS)
研究者
Dr SWATHI S L
G J Patel Institute of Ayurvedic Studies and Research Centre