Ulcerative colitis
Conditions
Interventions
treatment group:In the control group, 100 ml of Biyu Enema Solution was added to the basic treatment, administered once a night as a retention enema, for a treatment period of 12 weeks.
control group:Mesalazine 1.0 qid po,four times a day, orally after meals, for 12 weeks of treatment.
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-70, male or female; (2) Meet the diagnostic criteria of Western medicine for ulcerative colitis; (3) Meet the criteria for mild to moderate ulcerative colitis (active phase) according to the modified Mayo score, with no limitation on Montreal classification; (4) Meet the diagnostic criteria of traditional Chinese medicine, with a syndrome differentiation of damp-heat in the large intestine; (5) Those who agree to participate in the trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Pregnant and women preparing for pregnancy or lactation; (2) Other intestinal diseases (such as bacterial dysentery, acute infectious colitis, intestinal tuberculosis, and Crohn's disease); (3) Serious intestinal complications (such as intestinal perforation, intestinal obstruction, toxic megacolon, colorectal cancer); (4) Individuals with allergies and known allergies to the drugs intended for this trial; (5) Patients with severe primary diseases such as liver, kidney, and hematopoietic system, as well as psychiatric disorders; (6) Patients who have participated in clinical trials of other drugs within 4 weeks; (7) Use Chinese medicine or traditional Chinese patent medicines and simple preparations within 2 weeks; Therapists within the half-life of 5 biologics (such as 25.5 days for vedolizumab, 17.5 days for etanercept, 50 days for Infliximab, 70 days for Adalimumab, 105 days for ustekinumab, 135 days for Sikuximab, etc.); (8) Rectal stenosis, even obstruction, severe bleeding, and fistula formation in patients with proctitis require surgical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Mayo Score;StoolFrequency(SF) and Rectal Bleeding(RB);Traditional Chinese Medicine Syndrome Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| ulcerative colitis endoscopic index of severity,UCEIS;Inflammatory Bowel Disease Questionn-aire,IBDQ;Erythrocyte sedimentation rate, C-reactive protein; | — |
Countries
China
Contacts
Public ContactJianghong Ling
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed