Clinical trial NCT05780723: Treatment of Ulcerative Colitis With Rectal Instillation of Qinghua Quyu Prescription(QHQYP)
Official title: A Randomized Controlled Study of Qinghua Quyu Prescription Rectal Instillation for the Treatment of Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Traditional Chinese medicine diagnosis indicates the presence of damp-heat syndrome in the large intestine.
3. Between the ages of 18 and 65, regardless of gender.
4. Informed consent and voluntary participation are required. The process of obtaining informed consent should comply with GCP regulations.

Exclusion Criteria:

1. Patients with severe disease condition.
2. 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.
3. Patients with serious complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal polyps, toxic megacolon, colon cancer, rectal cancer, and anal diseases.
4. Pregnant or lactating women.
5. Patients with severe primary heart, liver, lung, kidney, blood or other severe diseases that affect their survival.
6. Patients with disabilities as defined by law (blind, deaf, mute, intellectually disabled, mentally ill, physically disabled).
7. Patients with suspected or confirmed history of alcohol or drug abuse.
8. 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.
9. Patients with allergies to two or more drugs or foods, or with a history of allergy to the components of this medication.
10. Patients currently participating in other clinical trials of medications.

Primary outcomes:
measure: Change from Modified Mayo Activity Index at 8 weeks of treatment
timeFrame: Evaluation will be made at baseline and 8 weeks of treatment.
Secondary outcomes:
measure: Change from Ulcerative Colitis Endoscopic Index of Severity(UCEIS) at 8 weeks of treatment
timeFrame: Evaluation will be made at baseline and 8 weeks of treatment.
measure: Change from Endoscopic Baron score at 8 weeks of treatment
timeFrame: Evaluation will be made at baseline and 8 weeks of treatment.
measure: Change from Geboes Score at 8 weeks of treatment
timeFrame: Evaluation will be made at baseline and 8 weeks of treatment.
measure: Change from Evaluation of curative effect of traditional Chinese medicine syndrome at 8 weeks of treatment
timeFrame: Evaluation will be made at baseline and 2,4,8 weeks of treatment.
measure: Change from Quality of life score at 8 weeks of treatment
timeFrame: Evaluation will be made at baseline and 8 weeks of treatment.
measure: Change from Intestinal flora at 8 weeks of treatment
timeFrame: Examination will be performed at baseline and 8 weeks of treatment.
Other outcomes:
measure: Change from Inflammation and immune-related indicators in colonoscopy biopsy tissues at 8 weeks of treatment
timeFrame: Examination will be performed at baseline and 8 weeks of treatment.
Locations:
city: Dongcheng
country: China
facility: Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Hospital of Traditional Chinese Medicine
name: Luqing Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.
citation: Jones GR, Lyons M, Plevris N, Jenkinson PW, Bisset C, Burgess C, Din S, Fulforth J, Henderson P, Ho GT, Kirkwood K, Noble C, Shand AG, Wilson DC, Arnott ID, Lees CW. IBD prevalence in Lothian, Scotland, derived by capture-recapture methodology. Gut. 2019 Nov;68(11):1953-1960. doi: 10.1136/gutjnl-2019-318936. Epub 2019 Jul 11.
citation: Ahmad R, Sorrell MF, Batra SK, Dhawan P, Singh AB. Gut permeability and mucosal inflammation: bad, good or context dependent. Mucosal Immunol. 2017 Mar;10(2):307-317. doi: 10.1038/mi.2016.128. Epub 2017 Jan 25.
citation: Wu Y, Tang L, Wang B, Sun Q, Zhao P, Li W. The role of autophagy in maintaining intestinal mucosal barrier. J Cell Physiol. 2019 Nov;234(11):19406-19419. doi: 10.1002/jcp.28722. Epub 2019 Apr 24.
citation: Li Q, Cui Y, Xu B, Wang Y, Lv F, Li Z, Li H, Chen X, Peng X, Chen Y, Wu E, Qu D, Jian Y, Si H. Main active components of Jiawei Gegen Qinlian decoction protects against ulcerative colitis under different dietary environments in a gut microbiota-dependent manner. Pharmacol Res. 2021 Aug;170:105694. doi: 10.1016/j.phrs.2021.105694. Epub 2021 Jun 2.