the Impact of Statin on Cirrhotic Patients
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
- impact on decompensation
研究概览
简要总结
The study aims to evaluate the impact of statin on hepatic decompensation.
详细描述
Cirrhosis is the late stage of liver damage and possess two phases:. The shift from compensated to decompensated cirrhosis is characterized by the onset of complications) which are associated with substantial morbidity and negative Impact on quality of life (QOL)Cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers
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)
盲法说明
Trial participants, investigators, care providers and outcome assessors were blinded to treatment allocation. Atorvastatin and placebo tablet were pre-filled in capsule and put into nontransparent sealed bottle to be identical in appearance. Unique randomization codes were set for each participant to avoid inadvertent loss of blinding for all participants if one is unblinded. Data analysis and manuscript writing were performed after unblinding when data had been cleaned for primary and secondary endpoints and adverse events (AEs).
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
- •Admissibility measures were age ranged from 18 to 75, with a medical diagnosis of decompensated liver cirrhosis built on standard clinical symptoms, laboratory tests, imaging appearances and/or liver biopsy. Decompensation of the disease was labeled by to the lowest degree having one episode of severe complications, including ascites, SBP, jaundice, EGVB and HE.8 All participants were ready to be enrolled and had signed up the informed consent.
- •The foremost
排除标准
- •involved the following: (1) life-deadly leukocytopenia (WBCs < 1 × 109/l); (2) Pregnant women or lactating mother; (3) patients diagnosed to have primary or secondary liver cancer.
研究组 & 干预措施
PLACEBO
placebo formula
干预措施: Placebo (Drug)
statin
atorvastatin tablets
干预措施: Atorvastatin 20mg (Drug)
结局指标
主要结局
impact on decompensation
时间窗: 6 months
change in recurrence of cirrhosis related complications
次要结局
未报告次要终点
研究者
Khadija Ahmed Mhrose Glal
Assistant lecturer of clinical pharmacy- Clinical pharmacy department- Faculty of pharmacy
Tanta University