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临床试验/NCT05511766
NCT05511766已完成2 期

The Potential Role of Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis: A Quadruple Blind Clinical Study

Tanta University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
150
试验地点
1
主要终点
recurrence number

研究概览

简要总结

The study aims to compare the potential benefit of allopurinol versus atorvastatin in reducing the risk of developing cirrhosis-related complications, delaying the onset of hepatocellular carcinoma, and improving survival. Furthermore, the study aims to evaluate their impact on parents' related quality of life.

详细描述

Cirrhosis is the late stage of liver damage and possess two phases: a compensated phase with favorable prognosis and a decompensated phase with high mortality rate1.The shift from compensated to decompensated cirrhosis is characterized by the onset of complications, including ascites, hepatic encephalopathy (HE), variceal bleeding, and spontaneous bacterial peritonitis (SBP) which are associated with substantial morbidity and negative Impact on quality of life (QOL)2.

The gut microbiota plays an important role in cirrhosis and development of cirrhosis-related complications3.

Indeed, translocation of endotoxins is increased in patients with cirrhosis and patients with more severe cirrhosis (i.e. Patients with decompensated cirrhosis, hospitalized patients) had significantly greater serum endotoxin concentrations that mediate complications of cirrhosis4.

Intestinal permeability plays a role in the development of bacterial translocation and may be involved in the development of complications of cirrhosis5. This 'leaky gut' phenomenon increases with the degree of liver failure and is particularly prominent in patients with cirrhosis who have experienced severe septic complications and has been implicated in the hepatic production of endotoxin-associated proinflammatory cytokines6.

Intestinal mucosa alterations at the subcellular level have been reported in experimental cirrhosis, in relation to an increased oxidative stress due to overactivity in the enzyme xanthine oxidase7.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion Criteria
  • •Age 18 to 75 years old
  • •Adults with cirrhosis in a stable conditions

排除标准

  • •Exclusion criteria
  • •Active SBP
  • •Renal insufficiency (serum creatinine > 2.0 mg/dl)
  • •Active GIT hemorrhage

研究组 & 干预措施

PLACEBO

Placebo Comparator

Group1: (Placebo, n=50) who will receive oral placebo tablet once daily FOR 6 MONTHS

干预措施: Placebo (Drug)

Simvastatin

Active Comparator

Group 3: (atorvastatin n=50) who will receive oral atorvastatin 20 mg daily for 6 months

干预措施: Atorvastatin 20mg (Drug)

Allopurinol

Active Comparator

Group 2:(Allopurinol n=50) who will receive oral allopurinol 300 mg daily for 6 months

干预措施: Allopurinol 300 MG (Drug)

结局指标

主要结局

recurrence number

时间窗: 6 months

acute decompensation events recurrence numbers

次要结局

  • validate a linical prediction model(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khadija Ahmed Mhrose Glal

Assistant lecturer of clinical pharmacy- Clinical pharmacy department- Faculty of pharmacy

Tanta University

研究点 (1)

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