Ulcerative colitis
Conditions
Interventions
Yiyi Fuzi Baijiang Powder Group:Treat with gradually decreasing dosage for 6 months (1 bag/time 2 times/day 3 months
1 bag/time 1 time/day 2 months
1 bag/time 2 days 1 month) observe for 3 months
Mesalazine sustained-release granules group:Treat with half of the induction dose for 6 months (1.0g/time, 2 times/day, course of treatment for 6 months), observe for 3 months
Sponsors
Beijing University of Traditional Chinese Medicine Dongzhimen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western diagnostic criteria for the remission period of chronic recurrent UC; (2) Meets the syndrome differentiation criteria of Yang deficiency and dampness stagnation in traditional Chinese medicine; (3) The frequency of occurrence in the past year is =2 times/year; (4) Age between 18 and 75 years old male or female not limited; (5) The patient agrees to participate in this study is willing to undergo relevant examinations and signs an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with severe complications such as toxic megacolon intestinal obstruction stenosis perforation and cancer; (2) Patients with severe diseases of the hematopoietic system liver kidney endocrine system etc; (3) Pregnant or lactating women; (4) Patients with mental illnesses; (5) Individuals with a history of allergies or severe food allergies to the drugs used in this study; (6) Patients who are currently participating in clinical trials of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No recurrence rate of rectal bleeding; | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic remission rate;Traditional Chinese Medicine Syndrome Score (Self designed);No recurrence rate of ulcerative colitis;Disease severity and patient activity were evaluated using the modified Mayo score;Microbial detection (intestinal microbiota);Metabolomics (Fecal Metabolomics);The appearance under electronic colonoscopy is evaluated using Baron endoscopic scoring;Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ);Safety indicators (blood routine, urine routine, liver function, kidney function, electrolytes);FC CXCL-1 CXCL-8 TNF-a IL-17 DUOX2(ELISA);Clinical remission rate;Recombinant Mucin 2 (immunohistochemistry);Histopathological evaluation using Geboes score; | — |
Countries
China
Contacts
Public ContactZhang Shuxin
Beijing University of Traditional Chinese Medicine Dongzhimen Hospital
Outcome results
None listed