Treatment of Ulcerative Colitis With Rectal Instillation of Qinghua Quyu Prescription(QHQYP)

NCT05780723 | Completed DMC

• 1 other identifier: Z221100007422094
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Change from Modified Mayo Activity Index at 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).

  Evaluation will be made at baseline and 8 weeks of treatment.

Secondary Outcomes (6)

• 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 Endoscopic Baron score 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.

Other Outcomes (1)

• Change from Inflammation and immune-related indicators in colonoscopy biopsy tissues at 8 weeks of treatment

  Examination will be performed at baseline and 8 weeks of treatment.

Study Arms (2)

The TCM group is treated with QHQYP by rectal instillation.

EXPERIMENTAL

QHQYP is decocted in water, with a dose of 100ml each time, and rectal instillation before going to bed, once a night, for 8 weeks.

Drug: Treatment group: Rectal instillation of QHQYP

The control group is treated with mesalazine enema.

ACTIVE COMPARATOR

Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, for 8 weeks.

Drug: Control group: Mesalazine enema treatment

Interventions

Treatment group: Rectal instillation of QHQYP DRUG

QHQYP is decocted in water, with a dose of 100ml each time, and rectal drip before going to bed, once a night, for 8 weeks.

Also known as: QHQYP is prepared by unified decocting from the Pharmacy Department of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.

The TCM group is treated with QHQYP by rectal instillation.

Control group: Mesalazine enema treatment DRUG

Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, a total of 8 weeks of continuous treatment.

Also known as: Mesalazine enema is produced by Vifor AG Zweigniederlassung Medichemie Ettingen, National medicine approval H20150127.

The control group is treated with mesalazine enema.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Dongcheng, Beijing Municipality, 100010, China

Location

Related Publications (5)

• 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.

  PMID: 29050646 BACKGROUND

• 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.

  PMID: 31300515 BACKGROUND

• 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.

  PMID: 28120842 BACKGROUND

• 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.

  PMID: 31020664 BACKGROUND

• 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.

  PMID: 34087350 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Luqing Zhao, Doctor

  Beijing Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 22, 2023
• Study Start: April 4, 2023
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)