Moderately Active Ulcerative Colitis
Conditions
Interventions
Control Group:Bawei Huangqin Enema Placebo (Simulant) Combined with Mesalazine Treatment
Treatment Group:Bawei Huangqin Enema Combined with Mesalazine Treatment
Sponsors
Dongfang Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: All of the following criteria must be fully met during screening for a patient to be enrolled in the trial: (1) Meets the diagnostic criteria for ulcerative colitis (UC), with a disease duration of 2 months or longer; has moderately active UC involving the left-sided colon or extensive colon; and has a modified Mayo score of 6–10 points (including 6 points and 10 points), among which the endoscopic score is = 2 points; (2) TCM syndrome differentiation is diagnosed as "dampness-heat stasis obstruction of the large intestine syndrome"; (3) Aged 18–65 years old (including 18 and 65 years old), regardless of gender; (4) Voluntarily participates in this clinical trial, understands the study information, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: A patient can be enrolled in the trial only if they do not meet any of the following criteria during screening: (1) Patients with ulcerative colitis (UC) in mild active phase, severe active phase, or remission phase; or patients with isolated ulcerative proctitis; (2) Patients with severe complications, such as local stenosis, intestinal obstruction, intestinal perforation, polyps with malignant potential, toxic megacolon, colon cancer, rectal cancer; or patients with other anal diseases that may affect drug administration or efficacy evaluation; (3) Patients with infectious colitis (e.g., bacillary dysentery, intestinal tuberculosis, amebic dysentery, chronic schistosomiasis) or diarrhea caused by non-infectious factors (e.g., Crohn's disease, ischemic colitis, radiation colitis); (4) Patients with a history of gastrointestinal surgery that may affect colonoscopy results, or patients with bleeding tendency; (5) Patients who used non-steroidal anti-inflammatory drugs (NSAIDs, via oral and/or rectal administration), corticosteroids (via oral, intravenous, intramuscular, or rectal administration), 5-aminosalicylic acid (5-ASA) preparations, or TCM medicines for UC (in any dosage form) within 7 days before screening; patients who used any immunomodulators/immunosuppressants within 60 days before screening; patients who received anti-tumor necrosis factor (anti-TNF) therapy within 6 months before screening; (6) Patients with hormone-dependent or hormone-refractory inflammatory bowel disease; (7) Patients with allergic diathesis; or patients allergic to 5-ASA and its derivatives, known components of the trial drug, any excipients, aspirin, or salicylic acid; (8) Women who are pregnant, plan to become pregnant during treatment or within 3 months after treatment completion; lactating women; patients of childbearing age (or their spouses) who cannot or are unwilling to use adequate contraception during treatment or within 3 months after treatment completion; (9) Patients with severe underlying diseases of the cardiovascular system, liver, kidneys, hematopoietic system, or endocrine system; patients with malignant tumors; or patients with mental illness; (10) Patients with alanine transaminase (ALT) or aspartate transaminase (AST) levels exceeding 1.5 times the upper limit of the reference range, or serum creatinine (Scr) levels exceeding the upper limit of the reference range; (11) Patients who cannot or are unwilling to cooperate with the completion of the clinical trial; (12) Patients with suspected or confirmed history of alcohol or drug abuse; (13) Patients who participated in other clinical trials within 3 months before screening or are currently participating in other drug clinical trials; (14) Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Effective Rate;Clinical Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Single Symptom Score;Traditional Chinese Medicine Syndrome Score;Endoscopic Response Rate;Mucosal Healing Rate;Quality of Life Score; | — |
Countries
China
Contacts
Public ContactLi Junxiang
Dongfang Hospital Beijing University of Chinese Medicine
Outcome results
None listed