A Randomized Controlled Study of Qinghua Quyu Prescription Rectal Instillation for the Treatment of Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Modified Mayo Activity Index at 8 weeks of treatment
研究概览
简要总结
This study will enroll 60 patients with mild to moderate active ulcerative colitis as subjects. They will be randomly divided into two groups: the TCM group received QHQYP rectal instillation, while the control group received mesalazine enema. The treatment period for both groups was 8 weeks. The modified Mayo Activity Index will be used as the main evaluation index. Secondary evaluation indices will include the Underwater Endoscopic Severity Index (UCEIS) score, endoscopic Baron score, mucosal histological score (Geboes index), Chinese medicine syndrome efficacy evaluation, quality of life score, physicochemical indicators reflecting disease activity or remission, intestinal microbiota indicators, and changes in inflammation and immune-related indicators in colonoscopy biopsy tissues. Safety indicators were also monitored.
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
- •Meets the diagnostic criteria for active ulcerative colitis, with clinical severity being mild or moderate and the lesion range being limited to the rectum or left colon and not extending beyond the splenic flexure.
- •Traditional Chinese medicine diagnosis indicates the presence of damp-heat syndrome in the large intestine.
- •Between the ages of 18 and 65, regardless of gender.
- •Informed consent and voluntary participation are required. The process of obtaining informed consent should comply with GCP regulations.
排除标准
- •Patients with severe disease condition.
- •Patients with infectious colonic diseases such as chronic schistosomiasis, bacterial dysentery, amoebic dysentery, intestinal tuberculosis, as well as non-infectious colonic diseases such as Crohn's disease, ischemic bowel disease, and radiation enteritis.
- •Patients with serious complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal polyps, toxic megacolon, colon cancer, rectal cancer, and anal diseases.
- •Pregnant or lactating women.
- •Patients with severe primary heart, liver, lung, kidney, blood or other severe diseases that affect their survival.
- •Patients with disabilities as defined by law (blind, deaf, mute, intellectually disabled, mentally ill, physically disabled).
- •Patients with suspected or confirmed history of alcohol or drug abuse.
- •Other conditions that may reduce the likelihood of enrollment or complicate enrollment, as determined by the researcher, such as frequent changes in work environment that may lead to loss of follow-up.
- •Patients with allergies to two or more drugs or foods, or with a history of allergy to the components of this medication.
- •Patients currently participating in other clinical trials of medications.
结局指标
主要结局
Change from Modified Mayo Activity Index at 8 weeks of treatment
时间窗: Evaluation will be made at baseline and 8 weeks of treatment.
To understand the remission status of ulcerative colitis from the stool frequency, rectal bleeding, colonic mucosa condition and physician's overall evaluation. Each of the above aspects includes four levels (from 0 to 3, with higher scores indicating more severe disease).
次要结局
- Change from Endoscopic Baron score at 8 weeks of treatment(Evaluation will be made at baseline and 8 weeks of treatment.)
- Change from Intestinal flora at 8 weeks of treatment(Examination will be performed at baseline and 8 weeks of treatment.)
- Change from Ulcerative Colitis Endoscopic Index of Severity(UCEIS) at 8 weeks of treatment(Evaluation will be made at baseline and 8 weeks of treatment.)
- Change from Geboes Score at 8 weeks of treatment(Evaluation will be made at baseline and 8 weeks of treatment.)
- Change from Evaluation of curative effect of traditional Chinese medicine syndrome at 8 weeks of treatment(Evaluation will be made at baseline and 2,4,8 weeks of treatment.)
- Change from Quality of life score at 8 weeks of treatment(Evaluation will be made at baseline and 8 weeks of treatment.)
研究者
Luqing Zhao
Principal Investigator
Beijing Hospital of Traditional Chinese Medicine