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临床试验/CTRI/2024/06/069222
CTRI/2024/06/069222已完成3 期

Comparative clinical trial to evaluate the efficacy of shuddha guggulu with and without virechana karma in dyslipidemia

Ayurvedic and unani tibbia college and hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月30日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Primary outcomes would be measured by lab investigation of extended lipid profile (

研究概览

简要总结

Cholesterol levels are estimated to cause 18% of the global CVDs and 56% of global ischemic heart disease (IHD). For every 1% reduction in lipid level , the risk of heart disease reduces by 2.5%. Dyslipidemia is a established risk factor for atherosclerotic disease. In india , there has been an alarming increase in the prevalence of CVD over the past two decades. In this view it is need of the hour to find a cost effective , non invasive treatment protocol to combat Dyslipidemia that May act as a preventive tactic for cardiovascular diseases.

This study is an attempt to explore the efficacy and add on effect of virechana karma  in dyslipidemic patients by normalizing lipid metabolism.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Any one of the dearranged parameter of lipid profile ( Total cholesterol, Triglyceride, LDL, HDL, VLDL) 2) Patient of either sex of age between 20 – 65.

排除标准

  • Patients who are contraindicated for virechana karma- like lower GI bleeding, Prolapse of rectum, incontinence of stool, Pregnant and lactating women will not be included in the trial in group A.
  • CAD patients , patients on any ongoing medications that are likely to affect lipid levels.
  • Patients with renal or hepatic impairement (Sr creatinine greater than 1.8mg/dl, SGPOT greater than 200u/L, SGPT greater than 280uL).
  • Patients with co-morbid conditions such as Hypertension grade 2 ( greater than or equal to 160/100mm of Hg) or more, Diabetes Mellitus (having HbA1c greater than 7.5 percent with or without hyperglycemic medications 5) Patients who are on anti tubercular , anti retroviral and anti hyperlipidemic medications.
  • Patients requiring emergency treatment.

结局指标

主要结局

Primary outcomes would be measured by lab investigation of extended lipid profile (

时间窗: Primary outcomes would be measured by lab investigation of extended lipid profile ( | including total cholesterol, triglyceride, ldl, vldl, hdl, apolipoprotein A1 and | apolipoprotein B) | On baseline | 60 days ,i.e, after completion of trial

including total cholesterol, triglyceride, ldl, vldl, hdl, apolipoprotein A1 and

时间窗: Primary outcomes would be measured by lab investigation of extended lipid profile ( | including total cholesterol, triglyceride, ldl, vldl, hdl, apolipoprotein A1 and | apolipoprotein B) | On baseline | 60 days ,i.e, after completion of trial

apolipoprotein B)

时间窗: Primary outcomes would be measured by lab investigation of extended lipid profile ( | including total cholesterol, triglyceride, ldl, vldl, hdl, apolipoprotein A1 and | apolipoprotein B) | On baseline | 60 days ,i.e, after completion of trial

次要结局

  • To asses the add on effect of virechana karma with Shuddha guggulu on Hs-CRP level.(The proportion of patients showing improvement in the quality of life using the)

研究者

发起方
Ayurvedic and unani tibbia college and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Manoj Shamkuwar

Ayurvedic and Unani Tibbia College and Hospital

研究点 (1)

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