“A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Vidangadi Lauha And Trayushanadi Lauha With Phalatrikadi Kwath In Medoroga (Dyslipidemia)”
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
Dyslipidemia is a disorder of lipid metabolism characterized by abnormal levels of serum lipids, including elevated total cholesterol, low-density lipoprotein (LDL), triglycerides, and/or reduced high-density lipoprotein (HDL). It is a major modifiable risk factor for cardiovascular diseases such as coronary artery disease, stroke, and peripheral vascular disease. Clinically, dyslipidemia may remain asymptomatic for long periods, eventually manifesting through complications affecting the heart, brain, and vascular system.
India is witnessing a rapid rise in the prevalence of dyslipidemia due to changing lifestyle patterns, urbanization, unhealthy dietary habits, and reduced physical activity, making it a significant public health concern. Although conventional treatments such as statins and other lipid-lowering agents are effective, long-term therapy is often associated with adverse effects, poor compliance, and economic burden. This highlights the need for exploring safe, effective, and sustainable alternative treatment modalities.
Ayurvedic management of dyslipidemia has shown promising results in improving subjective symptoms and lipid parameters; however, many studies report limitations such as small sample size and lack of comparative evaluation. Therefore, a systematic clinical assessment using appropriate study design is essential to establish evidence-based efficacy.keeping all these facts in mind, it has been decided to conduct a clinical study entitled as" A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIDANGADI LAUHA AND TRAYUSHANADI LAUHA WITH PHALATRIKADI KWATH IN MEDOROGA (DYSLIPIDEMIA)”.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •i)Adults in the age group of 18 to 60 years of either sex.
- •ii)LDLC more than and equal to 130 mg/dl and less than and equal to 190 mg/dl.
- •iii)Cholesterol more than and equal to 200 mg/dl and less than and equal to 300mg/dl.
- •iv)Triglycerides level more than and equal to 150 mg/dl and less than and equal to 300mg/dl.
- •v)Those who have voluntarily signed the written informed consent.
- •• If any one of the following criteria is met patient will be included .
排除标准
- •i)Patients having history of angina, Myocardial infarction and cerebrovascular accidents.
- •ii)Patients having Systolic blood pressure (SBP) & Diastolic blood pressure (DBP) more than an equal to 160 &100 mm of Hg respectively.
- •iii)Patients with uncontrolled diabetes mellitus with FBS level more than 160 mg/dl or HbA1c higher than 8%.
- •iv)Patients having hypothyroidism with TSH level more than and equal to 1.5 times the upper limit of normal.
- •v)Patients having statins, fibric acid derivatives, cholestyramine, nicotinic acid, proprotein convertase subtilisin/kexin type 9 inhibitors, corticosteroids, diuretics, amiodarone, cyclosporine.
- •vi)Patients with chronic disorders like Nephrotic syndrome, Renal failure, Auto immune disorders, Chronic Liver Disease (AST or ALT levels more than 2 times the upper limit of normal), and other serious diseases (vii)Pregnant women and lactating mother and females of child bearing age willing to conceive during trial period.
研究者
Varsha Yadav
National Institute of Ayurveda, Deemed to be university, Jaipur