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临床试验/NCT05545670
NCT05545670已完成2 期

Allopurinol Impact on Cirrhosis Related Complications

Tanta University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6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
100
试验地点
1
主要终点
morbidities

研究概览

简要总结

The study aims to compare the potential benefit of allopurinol 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 rate.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).

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

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 cirrhosis.

Intestinal permeability plays a role in the development of bacterial translocation and may be involved in the development of complications of cirrhosis. 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 cytokines.

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 oxidase.

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

入选标准

  • ge 18 to 75 years old Both sex Adults with cirrhosis in a stable conditions

排除标准

  • 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)

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

morbidities

时间窗: 6 moths

occurrence or exacerbation of complication

次要结局

未报告次要终点

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

Tanta University

研究点 (1)

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