Efficacy and safety of Ayurveda Formulation ‘Trikatu’ as add-on to standard care in Dyslipidemia- A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Change in fasting serum LDL cholesterol
研究概览
简要总结
Dyslipidemia, a common disorder characterized by abnormal levels of cholesterol, triglycerides, or both, and its association with cardiovascular risk and overall health. Dyslipidemia is an active area of research, and recent studies provide insight into its molecular basis and genetic origins, role in the development of atherosclerosis, and ability of pharmacological agents to ameliorate cardiovascular disease risk. In India, dyslipidemia is prevalent, and the focus on dyslipidemia management is urgently required to halt the rising tide of coronary heart disease. Lifestyle interventions and pharmacological therapy are the mainstay of management, but dietary interventions and Ayurvedic formulations like Trikatu can also help manage dyslipidemia. This study aims to assess the efficacy and safety of Trikatu for improving lipid parameters and regulating gut dysbiosis, which is now considered a marker of impaired metabolism. The study will be conducted by AIIMS, Bhubaneswar, and Central Ayurveda Research Institute, Bhubaneswar, with investigations carried out at Biochemistry Department and Central laboratory, AIIMS, Bhubaneswar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of moderate and high ASCVD risk dyslipidemia based on the ACC/AHA Guidelines, 2019 on the Primary Prevention of Cardiovascular Disease and indicated for statin therapy 2.Body Mass Index (BMI) ≥ 18.5 and < 34.9 kg/m².
- •Written informed consent provided prior to screening, after receiving and understanding the subject information.
- •Willingness to adhere to the treatment for a period of 12 weeks.
排除标准
- •Subjects on any lipid altering drug therapy other than statins
- •Patients of dyslipidemia with low ASCVD risk as per the ACC/AHA guidelines, 2019 and not indicated for statin therapy
- •Subject using or were using the following medications: systemic corticosteroids, cyclical or non-continuous hormone therapy (estrogen or testosterone).
- •within 6 weeks prior to screening
- •Pregnant, lactating mother, Smoker, alcoholic
- •Any other condition, that as per the PI would jeopardize the study/ study outcomes.
结局指标
主要结局
Change in fasting serum LDL cholesterol
时间窗: [ Time Frame: 0, 12 weeks ]
次要结局
- •Change in fasting Total cholesterol(•Changes in the Gut microbiota profile)
- •Change in Adiponectin, ghrelin, apolipoprotein A1 and apolipoprotein B levels(•Change in Hs-CRP, tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6))
- •Improvement in homeostatic model assessment to quantify insulin resistance (HOMA-IR)([ Time Frame: 0, 12 weeks ])
- •Proportion of participants in the normal reference range (less than 200 mg/dl) for fasting T. cholesterol([ Time Frame: 0, 12 weeks ])