Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Symptoms: frequency of stool
研究概览
简要总结
The exact efficacy of Zuoqing SAN enema in the treatment of Ulcerative colitis (UC) has been clinically verified. In this study, Zuoqing SAN was used to treat UC patients with large intestine damp-heat syndrome, and the traditional chinese medicine (TCM) syndrome type was large intestine damp-heat syndrome. The changes of symptoms and signs of patients before and after treatment were observed and compared, and the clinical efficacy of Zuoqing SAN in the treatment of UC large intestine damp-heat syndrome was evaluated by combining the changes of patients' symptoms, related blood indicators, improved Mayo total score, overall syndrome efficacy, clinical comprehensive efficacy and other aspects. By replicating the rat UC model, the effects of Zuoqing SAN on general survival state, colonic gross appearance and histopathological changes, related inflammatory factors, peroxisome proliferator-activated receptor γ (PPAR-γ) /nuclear factor kappa-B(NF-κB) /signal transducerand activator of transcription 1 (STAT1) pathway, macrophage M1, M2 phenotype and microangiogenesis were observed in UC rats. Thus, the specific mechanism of Zuoqing SAN in the treatment of UC was revealed. In this study, the therapeutic effect of Zuoqing Powder on UC was investigated through clinical and animal experiments, and the specific mechanism of action was studied.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •① Clinically diagnosed UC; ② The severity of UC is mild to moderate.
排除标准
- •① The severity of UC is severe; ②patient with Severe liver, kidney, heart and brain diseases; ③ Patients with Chinese medicine allergy; ④ Pregnant or lactation patients.
研究组 & 干预措施
Study Group
Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night
干预措施: Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night (Drug)
Control Group
Methalazine supposers anal once a day
干预措施: Methalazine suppository was given rectally once a day (Drug)
结局指标
主要结局
Symptoms: frequency of stool
时间窗: Follow-up for 6 months
Symptoms: frequency of stool in one day, or Daily number of bowel movements
次要结局
未报告次要终点
研究者
Heng Deng
Dr.
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
