NCT02347319已完成4 期
A Double-Blind, Randomized, Multicenter Trial Examining the Efficacy of Biphenyl Dimethyl Dicarboxylate Combined With Garlic Oil in Patients With Transaminase Elevated Chronic Liver Disease
PharmaKing1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Normalized rate in serum ALT
研究概览
简要总结
Purpose
- To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients with elevated transaminase chronic liver disease.
详细描述
Biphenyl dimethyl dicarboxylate (DDB) combined with garlic oil (pennel) has been used to treat chronic liver disease. A randomized, double-blind, active- and placebo-controlled clinical trial was conducted to investigate the efficacy, safety and quality of life in chronic liver disease patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 20years of age
- •Patients with more 60 ALT in screening period.
- •To evaluate ALT and AST at least three months.
- •Serum Transaminase abnormal(before 6months), chronic liver disease or fatty liver, liver disease medical treatment at more than 30days
- •Women of childbearing age get her consent for contraception, pregnancy urine test result negative.
排除标准
- •ALT>10UNL on screening period.
- •Current treatment on another clinical trial
- •Pregnancy or breastfeeding
研究组 & 干预措施
Pennel
Experimental
This group will treated with DDB 25mg/Garlic oil 50mg for 12 weeks.
干预措施: Pennel (Drug)
Legalon
Active Comparator
This group will treated with Silymarin 140mg for 12 weeks.
干预措施: Legalon (Drug)
Placebo
Placebo Comparator
This group will treated with Placebo for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Normalized rate in serum ALT
时间窗: 12 weeks
The rate of alanine aminotransferase (ALT) normalization
次要结局
- γ-GTP(8, 12 weeks)
- ALP(8, 12 weeks)
- Albumin(8, 12 weeks)
- ALT(8, 12 weeks)
- AST/ALT ratio(8, 12 weeks)
- Total Bilirubin(8, 12 weeks)
- AST(8, 12 weeks)
- The assessment of health-related quality of life(12 weeks)
研究者
研究点 (1)
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