The Potential Role of Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis: A Quadruple Blind Clinical Study
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
Group1: (Placebo, n=50) who will receive oral placebo tablet once daily FOR 6 MONTHS
干预措施: Placebo (Drug)
Simvastatin
Group 3: (atorvastatin n=50) who will receive oral atorvastatin 20 mg daily for 6 months
干预措施: Atorvastatin 20mg (Drug)
Allopurinol
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
Khadija Ahmed Mhrose Glal
Assistant lecturer of clinical pharmacy- Clinical pharmacy department- Faculty of pharmacy
Tanta University
