Ulcerative colitis
Conditions
Interventions
Experimental Group:Qingshenyin in combination with Salofalk (mesalazine enteric-coated tablets)
Qingshenyin, 150ml each time, twice daily, taken orally after breakfast and dinner
Salofalk, 1.0g each time, three times daily, taken orally, for an 8-week course.
Control Group:Salford (mesalazine enteric-coated tablets), 1.0g per dose, three times daily, orally, for an 8-week course.
Sponsors
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients with active ulcerative colitis who meet the diagnostic criteria, have colonoscopy findings consistent with ulcerative colitis within the past six months, have biopsy findings consistent with active ulcerative colitis, have a modified Mayo score of =3 and =10, have received adequate 5-aminosalicylic acid therapy for 2 weeks, and have been assessed as having an inadequate response based on clinical symptoms, signs, and inflammatory markers; (2) Patients who meet the diagnostic criteria for damp-heat pattern of the large intestine in traditional Chinese medicine; (3) Patients aged between 18 and 80 years, regardless of gender; (4) Patients who voluntarily participate in this study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with infectious enteric diseases such as bacterial dysentery, intestinal tuberculosis, or other enteric diseases such as ischemic colitis and colorectal cancer; (2) Patients who have used or are currently using anti-tumor necrosis factor agents, hormones, methotrexate, antibiotics, or other biologics within the 12 weeks prior to enrollment; (3) Patients with severe liver or kidney dysfunction, other autoimmune diseases, or concurrent malignant tumors; (4) Patients with a history of severe mental illness; (5) Patients allergic to or intolerant of the Chinese or Western medications used in this study; (6) Pregnant, postpartum, or breastfeeding women; (7) Patients who have participated in other drug clinical trials within the past 3 months; (8) Patients deemed unsuitable for participation in this study for other reasons by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcerative Colitis Clinical Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ulcerative Colitis Escalation Rate;Traditional Chinese Medicine (TCM) Syndrome Efficacy;Integration of Primary and Secondary Symptoms in Traditional Chinese Medicine;The cure rate of principal and secondary symptoms in Traditional Chinese Medicine.;Duration of relief from mucous and bloody stools; | — |
Countries
China
Contacts
Public ContactShan Jingyi
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed