A comparative clinical trial to evaluate the effect of Millet based diet module in MEDOJA VIKARA W.S.R. to 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
- 主要终点
- Serum levels of LDL
研究概览
简要总结
| Need of study: |
Allopathic hypolipidaemic drugs being used today have more adverse effects. Taking Ayurvedic Prescriptions for Dyslipidaemia for a long duration also becomes difficult in feasibility and economical aspects. Therefore, use of a dietary module which has slight side effects or is free from side effects is a need and necessity in the management of Dyslipidaemia. Millets have been gaining popularity in the present contexts as superfoods. They have been praised for their high nutritional values which has led to the celebration of the year 2023 as the ‘International Year of Millets 2023’. Epidemiological studies predict that for each 1% reduction in lipid level, the risk of Heart diseases reduces by 2.5%.[9] Keeping this fact in mind, this work is being done to evaluate the efficacy of Pearl Millet and Barnyard Millet, two important millets in Dyslipidaemia, a well-recognized risk factor for the increasing incidence of Cardiovascular diseases.
Aim and Objectives:
Aim: To study and evaluate the effect of Millet-based diet module in Medoja Vikara wsr to Dyslipidaemia.
Primary Objective: Evaluate the effect of Millet-based diet module in Medoja Vikara/Lipid Profile.
Secondary Objective: To compare the Millet-based diet module with the standard control group in lipid profile, BMI, skin fold thickness and Waist-hip ratio of patients with Dyslipidaemia.
Research Questions: Does millet-based diet module have effect in Changing the lipid profile of patients presenting with dyslipidaemia?
Null Hypothesis: Millet based diet module does not have any effect in changing lipid profile of patients of Dyslipidaemia.
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
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 20 to 65 years irrespective of gender cast and religion Patients of Dyslipidaemia having serum LDL cholesterol levels more then 100 mg/dL with or without Total cholesterol levels more then 200 mg/dL HDL Cholesterol levels less then 40 mg/dL Triglycerides levels more then 150 mg/dL No acute or chronic pathology Patients who will give consent.
排除标准
- •Any renal or hepatic disease or a heart condition Uncontrolled endocrine disease diabetes mellitus or gastrointestinal disease interfering with drug absorption Undergoing other therapies for high cholesterol or anticoagulant therapy Pregnant and lactating women.
结局指标
主要结局
Serum levels of LDL
时间窗: 12 weeks
次要结局
- Serum levels of Total Cholesterol, HDL, VLDL, Triglycerides(12 weeks)
研究者
Dr Kashinath Samagandi
National Institute of Ayurveda Jaipur Rajasthan