Open Labelled, Active Controlled, Randomized Comparative Clinical Trial to Evaluate the Efficacy of Arthrakshak-DM in the Management of Diabetic-induced Dyslipidemia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Diabetic dyslipidemia is a common metabolic disorder in patients with type 2 diabetes mellitus and is associated with increased risk of cardiovascular diseases. It commonly occurs due to decreased insulin sensitivity leading to altered lipid metabolism in diabetic patients. Conventional lipid lowering drugs such as statins are effective but may be associated with long term adverse effects and intolerance in some patients. Ayurveda describes dyslipidemia under conditions such as Medoroga and Kapha Medo Dushti.
The present study is an open label randomized active controlled clinical trial designed to evaluate the effect of an Ayurvedic formulation Arthrakshak DM in comparison with Atorvastatin in patients with type 2 diabetes induced dyslipidemia. A total of 60 eligible participants will be randomly allocated into 2 groups. Group A will receive Arthrakshak DM capsules while Group B will receive Atorvastatin tablets for a duration of 90 days.
The primary outcome measures include changes in lipid profile parameters such as total cholesterol low density lipoprotein high density lipoprotein and triglycerides. Changes in serum insulin levels and insulin sensitivity will also be observed to assess their role in diabetic induced dyslipidemia. Secondary outcome measures include changes in fasting blood sugar HbA1c body weight body mass index and improvement in subjective symptoms related to dyslipidemia. Safety will be assessed by monitoring adverse events throughout the study period.
This study aims to assess whether Arthrakshak DM is effective and safe in managing diabetic dyslipidemia and to generate clinical evidence for its potential role as an alternative or complementary treatment option.
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender aged between 18 years and 70 years both years inclusive.
- •Patients having HbA1c levels between 6.5 percent and 10.0 percent indicating Type 2 Diabetes Mellitus.
- •Patients must meet at least one of the following lipid profile criteria as per ADA ESC LAI thresholds according to 2024 guidelines.
- •Low density lipoprotein cholesterol equal to or more than 100 milligram per decilitre.
- •Triglyceride level equal to or more than 150 milligram per decilitre.
- •Non high density lipoprotein cholesterol equal to or more than 130 milligram per decilitre.
- •High density lipoprotein cholesterol equal to or less than 40 milligram per decilitre in males or equal to or less than 50 milligram per decilitre in females.
排除标准
- •Patients having severe dyslipidemia with total cholesterol more than 360 milligram per decilitre.
- •Patients having low density lipoprotein cholesterol more than 190 milligram per decilitre.
- •Patients having triglyceride levels more than 400 milligram per decilitre.
- •Patients having high density lipoprotein cholesterol more than 40 milligram per decilitre in males or more than 50 milligram per decilitre in females.
- •Patients with dyslipidemia due to drug induced causes such as glucocorticoids.
- •Patients with a recent history of myocardial infarction heart failure or stroke.
- •Pregnant and lactating women.
- •Patients with a history of alcoholism.
- •Patients with known immunosuppressive conditions such as human immunodeficiency virus infection.
- •Patients with known active infectious diseases such as tuberculosis or hepatitis B.
研究者
Dr Jayant Sharma
Parul Institute of Ayurved