NCT05780723Completed
Treatment of Ulcerative Colitis With Rectal Instillation of Qinghua Quyu Prescription(QHQYP)
A Randomized Controlled Study of Qinghua Quyu Prescription Rectal Instillation for the Treatment of Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 18 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 8 Mar 2023
- Start date
- 4 Apr 2023
- Primary completion date
- 23 Oct 2024
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Diseases
- Ulcerative colitis
- NCT number
- NCT05780723
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 4 Apr 2023 to the primary completion date, 23 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently participating in other clinical trials of medications.
Other illness
- 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.
- Patients with severe primary heart, liver, lung, kidney, blood or other severe diseases that affect their survival.
- 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.
Other
- Pregnant or lactating women.
- Patients with disabilities as defined by law (blind, deaf, mute, intellectually disabled, mentally ill, physically disabled).
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Coordinator of this site? Confirm its status | Dongcheng | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.