NCT00963287已完成不适用
Trial of Chinese Prescription on Ulcerative Colitis
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: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription on Ulcerative Colitis.
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
- Double (Participant, 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 ulcerative colitis
- •Male of female patients between 18-65 years old
- •Written informed consent
排除标准
- •Combine with malignant pathology on epithelial dysplasia of mucosa
- •Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
- •Pregnancy or breast feeding women, or unwilling to have contraception.
研究组 & 干预措施
bascial prescription
Experimental
Decoction ,two times a day,one bag of decoction one time
干预措施: bascial prescription plus or minus herbs depend on symptoms (Drug)
low does of bascial decoction
Placebo Comparator
Decoction ,two times a day, one bag decoction of one time
干预措施: bascial prescription plus or minus herbs depend on symptoms (Drug)
结局指标
主要结局
Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration
时间窗: 8 weeks
次要结局
- Indicates of liver and renal function(8 weeks)
研究者
研究点 (1)
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