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临床试验/CTRI/2026/01/100241
CTRI/2026/01/100241尚未招募4 期

Assessment of efficacy and safety of rosuvastatin as an adjunct to lifestyle modification in patients of metabolic dysfunction-associated-fatty liver disease (MAFLD): a prospective randomised controlled trial

Government Medical College Patiala1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年1月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
70
试验地点
1

研究概览

简要总结

MAFLD (Metabolic dysfunction- associated fatty liver disease) is one of the most common chronic liver disease affecting 32.4% of the global population. MAFLD is defined as a liver disorder caused by accumulation of excess fat (>5%) in liver cells also known as steatosis or fatty liver, which is not necessarily caused by significant alcohol consumption.MAFLD is closely related with obesity, type 2 diabetes mellitus, dyslipidemia, hypertension, coronary artery disease, metabolic syndrome etc. MAFLD includes a spectrum of conditions ranging from simple hepatic steatosis to non-alcoholic steatohepatitis (NASH), which can progress to liver fibrosis, cirrhosis, liver failure, and hepatocellular carcinoma (HCC).While efforts have made to develop effective treatment for MAFLD but the need of pharmaceutical interventions still remains unmet. Currently standard of care only includes lifestyle modification such as healthy diet, regular physicial activity, weight loss, reduced free sugars etc. Pharmacological interventions are still under development and there is no specific medication that has been approved as a standard treatment. statins in addition to hypolipidemic effects,have other pleiotropic effects including anti thrombotic, antifibrotic and anti-inflammatory properties. These properties make statins potentially useful in preventing the progression of MAFLD to more severe forms like steatohepatitis, cirrhosis .Recent studies across the globe have found statins to be useful in causing reduction in liver fat , improvement in liver function tests indicating improvement in liver function.

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 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Adults of either gender in the age group of 18-65 years 2.Patients with confirmed diagnoses of MAFLD 3.Patient suffering from obesity, dyslipidemia, hypertension and hypercholestronemia (Metabolic syndrome).
  • 4.Patients who provide written informed consent for study participation.

排除标准

  • 1.Individuals with known causes of liver injury such as viral hepatitis, autoimmune liver disease etc.
  • 2.Patients taking excessive alcohol.
  • (Male more than 21drinks per week Female more than 14 drinks weeks per week) 3.History of any drug abuse 4.Pregnant and lactating women 5.Patient already on statins treatment 6.Patient with known contraindications to rosuvastatin.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Amrit Kaur

Government Medical College , Patiala

研究点 (1)

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