Multicenter, Randomized, Placebo-Controlled, Double-blind Phase 2 Study to Evaluate the Short-term Efficacy, Safety and Tolerance and to Find an Optimal Dosage of the PENNEL Capsule for the Patients With Chronic Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- ALT (Alanine Aminotransferase)
研究概览
简要总结
The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic oil. The two components were confirmed to have complementary effects because of different operational mechanism in animal experiments, and were examined on humans in this study. Both BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity caused by toxic substances, and the purpose of this study is to confirm efficacy of and safety on human body of the agent and to determine its optimal dose.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic liver disease.
- •Patients over 20, under 65 years of age.
- •Patients with abnormal transaminase levels.
排除标准
- •Pregnant and lactating women.
- •Patients who have any history of esophageal bleeding, hepatic encephalopathy, ascites.
- •Diabetes, thyroid dysfunction, fatty liver, liver cancer patients.
- •Toxic hepatitis, alcoholic hepatitis.
- •Total bilirubin value more than 3.0 mg/dl.
- •Albumin value less than 3.0 g/dl.
- •Patients who participating in other study about drug.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
PENNEL capsule
1cap or 2cap T.I.D
干预措施: PENNEL capsule (Drug)
结局指标
主要结局
ALT (Alanine Aminotransferase)
时间窗: 6 week
To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 6 weeks (Change from Baseline in Alanine Aminotransferase at 6 weeks) The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.
次要结局
- AST (Aspartate Aminotransferase)(6 weeks)
- g-GT (γ-glutamyl transpeptidase)(6 weeks)
- Total bilirubin(6 weeks)