NCT00543426已完成4 期
Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
Shanghai University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年9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
- 200
- 试验地点
- 1
- 主要终点
- the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis
研究概览
简要总结
The primary purpose of the trial is adopted Fuzheng Huayu tablets against posthepatitic cirrhosis, and to build a standard evaluation system for efficacy of traditional Chinese medicine (TCM).
The second purpose is according to the international clinical guideline and the specialty of TCM to build a standard clinical trial regulation for traditional Chinese medicine.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of B Post hepatitic cirrhosis.
- •Male or female patients between 18~65 years old.
- •Written informed consent.
排除标准
- •Child-Pugh C above 12, or ALT > 2×ULN, TBiL > 2×ULN, or combined with hepatic encephacopathy, Obstinate ascites, bleeding tendency, hepato-renal syndrome, or primary liver cancer.
- •Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
- •Deformed man by the law.
- •Pregnancy or breast feeding women, or unwilling to have contraception.
- •Irritability body constitution, or irritability of the Fuzheng Huayu Capsules.
- •Enter other trials lately one month.
- •Other cause of cirrhosis.
研究组 & 干预措施
1
Experimental
Fuzheng Huayu Tablets
干预措施: Fuzheng Huayu Tablets (Drug)
2
Sham Comparator
sham Fuzheng Huayu Tablets
干预措施: sham Fuzheng Huayu Tablets (placebo) (Drug)
结局指标
主要结局
the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis
时间窗: six months
次要结局
- hepatic function; blood test; blood ammonia and blood sugar determination(six months)
研究者
研究点 (1)
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