Add On Effect Of Mudga Yusha With Lifestyle Modifications In Dyslipidemia.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum Total Cholesterol, LDL Cholesterol, Triglycerides, HDL Cholesterol
研究概览
简要总结
Dyslipidemia is the disorder of lipoprotein metabolism, including lipoprotein overproduction or deficiency. These disorders may be manifested by elevation of the serum total cholesterol, low-density lipoprotein (LDL) cholesterol and triglyceride concentrations, and a decrease in the high-density lipoprotein (HDL) cholesterol concentration. It is one of the commonest presentation & major cause for various lifestyle disorders. Treating early borderline dyslipidemia is one of the key factors for prevention of CVD and atherosclerosis. A combination of exercise and diet therapy can be considered to be particularly advantageous because diet and exercise elicit complementary effect on lipid profiles. Being a metabolic disorder, Dyslipidemia can be very well managed by diet and exercise.
In Ayurvedic classics, most of the scholars have considered Dyslipidemia under the heading of medoroga. Dietary interventions with legumes received special attention around the world because of the hypocholesterolemic and liver-protective properties of legumes. In Ayurveda, Mudga is explained as a pathya in medoroga. In Ayurvedic classics under the Kritannakalpana, Yusha is mentioned. Mudga Yusha and lifestyle modifications can reduce errors in cholesterol metabolism. This study aims to assess the add on effect of Mudga Yusha with lifestyle modifications in dyslipidemia.
A Quasi experimental study will be performed in 60 participants irrespective of sex , satisfying inclusion and exclusion criteria. Out of 60 participants, 30 each will be allocated to study group (Group 1) and control group (Group2).The participants in group 1 will be instructed to consume 192ml of Mudga yusha before breakfast along with Lifestyle modifications such as dietary restrictions and exercise for 90 days while Lifestyle modifications alone will be advised to Control group. The study period is 90 days. Through serum lipid profile investigation, the outcome measurements will be analyzed before and after the study (0th and 91st day).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants irrespective of sex Participants in the age group of 30-60 years On the basis of ATP â…¢ Guidelines, either having variation in Serum total cholesterol 200mg/dL.
- •239mg/dL Having LDL Cholesterol between 130mg/dL.
- •159mg/dL Having Triglycerides between 150mg/dL.
- •199mg/dL Having HDL Cholesterol less than 40mg/dL Participants who are willing to give informed consent.
排除标准
- •Participants with chronic systemic illness Known case of Renal disorders under medications Known case of Dyslipidemia under medications Pregnant women and lactating mothers Known history of allergy to Mudga(Green gram).
结局指标
主要结局
Serum Total Cholesterol, LDL Cholesterol, Triglycerides, HDL Cholesterol
时间窗: 0th day, 91st day
次要结局
- Body Mass Index(0th day, 91st day)
研究者
Dr Ariya N S
Government Ayurveda Medical College and Hospital, Thiruvananthapuram