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临床试验/NCT06667934
NCT06667934尚未招募1 期

Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine0 个研究点目标入组 60 人开始时间: 2024年10月30日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Active Comparator

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

发起方
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Heng Deng

Dr.

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

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