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临床试验/CTRI/2023/07/055320
CTRI/2023/07/055320尚未招募2 期

Evaluation of the safety and efficacy of Qurs Tinkar for the management of dyslipidemia - A randomized controlled trial

Luqman Unani Medical college hospital and research centre1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年7月28日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Changes in the levels of:

研究概览

简要总结

Dyslipidemia is a group of lipoprotein metabolism diseases characterized by increased serum total cholesterol, triglycerides and LDL, and decreased serum cholesterol concentration and HDL This is the most significant risk factor for cardiovascular diseases and atherosclerosis. In India, the prevalence of hypercholesterolemia ranges from 10-15 in rural areas to 25-30 in metropolitan areas. However, this prevalence is lower than in countries with a high income. Several health behaviors, including cigarette use, physical inactivity, diet, and obesity, can have affects and elevate lipid levels However, there is a complex relationship between obesity and dyslipidemia, which influences insulin resistance and body fat metabolism directly. In addition, because dyslipidemia affects lipid metabolism, it is commonly accompanied by obesity. Excessive fat deposition in obesity also has a complex origin but is commonly attributed to an imbalance between energy expenditure and energy intake.  Despite special public health measures and individual treatment initiatives to tackle the obesity epidemic, more than 2 billion individuals are overweight or obese worldwide. Initial management for dyslipidemia involves lifestyle modifications and then lipid lowering thrapies. 

First-line treatment for dyslipidemia is statins that inhibit HMG-CoA reductase  The limitations of present therapy, the high incidence of the disease, life-threatening consequences, and the side effects of conventional medicines have increased the potential for the creation of a safe, effective, and economical therapeutic intervention for dyslipidaemia.

Unani medicine, which is based on Hippocratic concepts, may offer preventative strategies, therapeutic techniques, and medications to treat dyslipidemia. Although there is no direct description of dyslipidemia in Unani literature, scholars have characterized it under the general titles of Dasumat-i Dam (greasy blood) and Siman-i Mufrit (excessive fat condition), as well as the abnormalities of Hazm-i Kabidi (hepatic digestion), as the primary cause of dyslipidemia The principles of treatment revolve around TajfÄ«f-i Badan (desiccation), TahzÄ«l (weight loss), and TaqlÄ«l-i GhizÄ (reduction in the quantity of food) . Pharmacologically a number single and compound drugs are prescribed by renowned Unani scholars in ancient literature in which Qurs Tinkar is prescribed to reduce fat and constipation , but scientific evidence is scarce.

Thus, present study is designed to compare the safety and efficacy of Qurs Tinkar with atorvastatin in the management of dyslipidemia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants of any gender.
  • Age between 20 and 60 years.
  • Participants with serum cholesterol more than or equal to 200mg per dL, serum triglycerides(TG) more than or equal to 150mg per dL, Low Density Lipoprotein cholesterol (LDL) more than or equal to 130mg per dL, High Density Lipoprotein (HDL) less than or equal to 40 mg per dL.

排除标准

  • Participants with comorbidities such as IHD, hypertension, diabetes, chronic kidney disease, malignancy, and other aggravating conditions.
  • Pregnant & lactating women.

结局指标

主要结局

Changes in the levels of:

时间窗: At baseline and 3 months.

LDL-C

时间窗: At baseline and 3 months.

HDL-C

时间窗: At baseline and 3 months.

次要结局

  • Changes in the levels of:(Total cholesterol,)

研究者

发起方
Luqman Unani Medical college hospital and research centre
申办方类型
Private medical college

研究点 (1)

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