A Multicenter, Randomized, Double-blind, 2 Parallel Group, Phase 3 Study of PENNEL Capsule in Chronic Liver Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- ALT(Alanine Aminotransferase)
研究概览
简要总结
The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and garlic oil. This components showed synergistic enhancing effects in previous tests. In phase 2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on above, this study is phase 3 test to prove efficacy and safety of PENNEL.
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 diagnosed with chronic hepatitis by biopsy
- •Patients over 20, under 65 years of age.
- •Patients with abnormal transaminase value.
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
PENNEL
2cap T.I.D
干预措施: PENNEL (Drug)
NISSEL
NISSEL
BDD (biphenylmethyl dicarboxylate) ................25mg
2cap T.I.D
干预措施: NISSEL (Drug)
结局指标
主要结局
ALT(Alanine Aminotransferase)
时间窗: 10 weeks
To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 10 weeks (Change from Baseline in Alanine Aminotransferase at 10 weeks) The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration
次要结局
- AST (Aspartate Aminotransferase)(10 weeks)
- g-GT (γ-glutamyl transpeptidase)(10 weeks)
- Total bilirubin(10 weeks)
- PLT (Platelet)(10 weeks)
- Total cholesterol(10 weeks)