Treatment of Ulcerative Colitis With Rectal Instillation of Qinghua Quyu Prescription(QHQYP)
NCT ID: NCT05780723
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2023-04-04
2024-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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The TCM group is treated with QHQYP by rectal instillation.
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.
Treatment group: Rectal instillation of QHQYP
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.
The control group is treated with mesalazine enema.
Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, for 8 weeks.
Control group: Mesalazine enema treatment
Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, a total of 8 weeks of continuous treatment.
Interventions
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Treatment group: Rectal instillation of QHQYP
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.
Control group: Mesalazine enema treatment
Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, a total of 8 weeks of continuous treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Hospital of Traditional Chinese Medicine
OTHER
Responsible Party
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Luqing Zhao
Principal Investigator
Principal Investigators
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Luqing Zhao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Hospital of Traditional Chinese Medicine
Locations
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Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Dongcheng, Beijing Municipality, China
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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Z221100007422094
Identifier Type: -
Identifier Source: org_study_id