CTRI/2024/11/076376尚未招募4 期
Assessment of efficacy of Dapagliflozin in patients of Liver Cirrhosis with Ascites
No1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年11月20日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Reduction in grade of Ascites
研究概览
简要总结
All the new patients of Liver Cirrhosis with Ascites and patients of Ascites uncontrolled on diuretics shall be enrolled. The study shall be conducted in the Hepatology clinic , Department of Medicine, Pt B.D. Sharma PGIMS , Rohtak. The study is a parallel group, open label , randomised controlled study. Enrolment shall be done for first 6 months , all patients shall be followed upto 6 months after enrolment.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All the patients of liver cirrhosis with new onset ascites and patients of ascites uncontrolled on diuretics therapy shall be enrolled.
排除标准
- •Age less than 18 years, Cerebrovascular disorder, any neurological disorder including dementia/ Alzheimer’s etc., Pregnancy and Any extrahepatic malignancy.
结局指标
主要结局
Reduction in grade of Ascites
时间窗: 3 and 6 months.
次要结局
- Episodes of Acute kidney injury (AKI)/ spontaneous bacterial peritonitis/ hepatic encephalopathy/ jaundice and Change in CTP and MELD score.(3 and 6 months)
研究者
Dr Ravi Dhayal
Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak , Haryana
研究点 (1)
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