A Randomized Open Labelled Placebo Controlled Trial to Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.
研究概览
简要总结
After successful screening of liver cirrhosis patients attending ILBS OPD for signs of parkinsonism ( tremor, rigidity or bradykinesia, any 2 of 3). Diagnosis of hepatic/cirrhosis related parkinsonism will be made. Patients will be randomized into Bromocriptine and Placebo. Patients will be followed up every month in OPD (Out Patient Department), ILBS (Institute of liver & Biliary Sciences) for 3 months. Detailed neurological examination will be done at each visit & UPDRS (Unified Parkinson's Disease Rating Scale ) score will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cirrhosis of liver with signs of parkinsonisms
- •Patients consented for the study protocol by signing the informed consent.
排除标准
- •Age < 18 years.
- •Patient s with HCC (Hepatocellular Carcinoma).
- •Patients diagnosed as Wilsons disease.
- •Patient who withdrew or non complaint to the study protocol.
- •ALF (Acute Liver failure)
- •Classical Parkinsonism
- •Atypical Parkinsonism
- •Pregnancy
- •Hypotension
- •Uncontrolled hypertension
- •Psychiatric illness
- •Acute episode of Hepatic encephlopathy
研究组 & 干预措施
Lactulose + Rifaximin + Bromocriptine
干预措施: Lactulose+Rifaximin +Bromocriptine (Drug)
Lactulose+Rifaximin+Placebo
干预措施: Lactulose+Rifaximin +Bromocriptine (Drug)
结局指标
主要结局
The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.
时间窗: 3 months
次要结局
- The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.(3 months)