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临床试验/CTRI/2024/07/070818
CTRI/2024/07/070818尚未招募不适用

A Randomized open labelled controlled clinical study to evaluate the efficacy of Yogaraja guggulu in the management of Medoroga with special reference to Dyslipidemia.

Dr Krishna sai P1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Changes in Serum Lipid profile

研究概览

简要总结

Dyslipidemia is a disorder of lipoprotein metabolism,which may include lipoprotein overproduction or deficiency,or both. this leads to elevated total cholesterol,low density lipoprotein cholestrol(LDL-C) and triglycerides(TG) concentrations, and a decrease in the high density lipoprotein cholesterol(HDL-C) concentration in blood.

Dyslipidemia is a key independent risk factor for coronary heart disease(CAD),which in turn promotes the growth of Atherosclerosis and related cardiovascular events. Dyslipidemia has been strongly linked to the pathophysiology of cardiovascular diseases(CVDs).

About 25-30% of urban and 15-20% of rural individuals in india have dyslipidemia,2019.

Statins,cholesterol absorption inhibitors,fibrates,nicotinic acid,and others are frequently used drugs in the pharmacologocal intervention in dyslipidemia,but their use is associated with serious side effects like myalgias,arthralgias,dyspepsia,hepatic toxicity,and others.

Dyslipidemia can be understood in Ayurveda in terms of Medoroga,a disorder caused by medo dhatu vriddhi, which can lead to bahutwa and abaddhatwa of medo datu.

Given the prevalence and adverse effects of long tern use of contemporary interventions,it is necessary for more effective, and cost efficient medicines to control the illness and serve society.

Though numerous Ayurvedic formulations have been demonstrated to have anti-hyperlipidemic efficacy with no documented side effects, there is still scope for more research in this field.

Thus yogarajaguggulu,a medohara yoga,mentioned by Acharya sharangdhara, attributed with Hypolipidemic,Cardio protective and Hepatoprotective activity is taken for the present study.

Navakaguggulu consisting of maricha,pippali,shunti,harithaki,vibhitaki,amalaki,chitraka, and musta mentioned by bhaishajyaratnavali, being a proven drug for medoroga is taken as control drug.

E78.9 is the ICD-10-CM code used for diagnosing Disorder for lipoprotein metabolism,unspecified.

EF-3 is the specific code as per NAMASTE PORTAL (National Ayush Morbidity and standardized terminologies electrical portal) for Medoroga.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • • Subjects of either gender between the age group of 21-60 years.
  • • Subjects who full fill the diagnostic criteria.
  • • Both obese and non obese subjects will be included.
  • • Subjects willing to participate with written informed consent, which is conveyed in the language, which the subject can understand.
  • • Subjects with only Grade 1 & Grade 2 Dyslipidemia would be taken .

排除标准

  • • Subjects who are on any medication for Dyslipidemia.
  • • Subjects with any uncontrolled systemic illness like Diabetes Mellitus, Hypertension • Pregnant and Lactating women.

结局指标

主要结局

Changes in Serum Lipid profile

时间窗: before intervention- 0th day | after intervention- 30th day | follow up- 45th day

次要结局

未报告次要终点

研究者

发起方
Dr Krishna sai P
申办方类型
Other [[self]]
责任方
Principal Investigator
主要研究者

Dr Krishna sai P

Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore

研究点 (1)

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