NCT03216668Unknown3 期
A Randomized, Active-Control, Open Label, Phase IIIb Study to Evaluate the Safety and Efficacy of TONKA Compared With Silymarin (Legalon) for Lowering Hepatic Enzymes in Liver Function Disorder Patients With Moderate to High Elevated Liver
Nhat Nhat Pharmaceutical Company1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The percentage of patients with ALT reduced to less than or equal to 60 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy TONKA on the reduction of ALT and AST in moderate to severe liver enzyme elevated patients; compared with Silymarin (Legalon) after 6 weeks of treatment.
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
- •Male and Female more than 18 year old.
- •Diagnosed as Alcoholic Liver Disease (ALD), or Non Alcoholic Fatty Liver Disease (NAFLD), or Liver Function Disorders due to Drugs or Chemicals.
- •ALT at baseline is in between 150 U/L to 400 U/L
- •Sign the informed consent form
排除标准
- •Hepatitis B or C.
- •Pregnant or Lactating women
研究组 & 干预措施
TONKA
Experimental
Administered orally twice a day, 2 tablets each time, for 6 weeks
干预措施: TONKA (Drug)
LEGALON
Active Comparator
Administered orally three times a day, two tablets each time, for 6 weeks
干预措施: LEGALON (Drug)
结局指标
主要结局
The percentage of patients with ALT reduced to less than or equal to 60 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
时间窗: 6 weeks
次要结局
- The percentage of patients with ALT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)(6 weeks)
- The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)(6 weeks)
- The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon)(6 weeks)
- The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon)(6 weeks)
- The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The percentage of patients with ALT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The percentage of patients with GGT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The percentage of patients with GGT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The percentage of patients with ALT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon).(6 weeks)
- The number of participants with clinically significant vital sign parameters at week 6, compared between Tonka and Silymarin (Legalon).(6 weeks)
- The percentage of patients with AST reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The percentage of patients with AST reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)(6 weeks)
- The percentage of patients with GGT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)(6 weeks)
- The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)(6 weeks)
- The percentage of patients with AST reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)(6 weeks)
- The percentage of patients with GGT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)(6 weeks)
- The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)(6 weeks)
- The percentage of patients with ALT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)(6 weeks)
- The percentage of patients with AST reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)(3 weeks)
- The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon)(6 weeks)
研究者
研究点 (1)
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