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临床试验/NCT02642861
NCT02642861Unknown3 期

Cyclobenzaprine Treatment for Muscle Cramps in Cirrhotic Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
200
试验地点
1
主要终点
Number of muscle cramps

研究概览

简要总结

  • Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

详细描述

Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking.

  • Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Liver cirrhosis and has frequent muscle cramps

排除标准

  • Allergy to cyclobenzaprine
  • Encephalopathy.
  • Receiving antidepressant drugs

研究组 & 干预措施

Cyclobenzaprine

Active Comparator

Cyclobenzaprine administration for 2 weeks

干预措施: Cyclobenzaprine (Drug)

PLacebo

Placebo Comparator

Calcium carbonate for 2 weeks

干预措施: Calcium Carbonate (Drug)

结局指标

主要结局

Number of muscle cramps

时间窗: 3 months

The number of muscle cramps

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

Sherief Abd-Elsalam

Consultant liver and GIT diseases- Tanta university hospital

Tanta University

研究点 (1)

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