Ulcerative colitis
Conditions
Interventions
Traditional Chinese Medicine Group:Sanrenkushen Formula instant granules + mesalazine enteric-coated tablets placebo
Western Medicine Group:Mesalazine enteric-coated tablets + traditional Chinese medicine instant granules placebo
Integrated Chinese and Western Medicine Group:Sanrenkushen Formula instant granules + mesalazine enteric-coated tablets
Sponsors
Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients whose Western medicine diagnosis conforms to those in the active stage of ulcerative colitis; (2) According to the modified Mayo scoring standard, the condition belongs to mild to moderate (score 3-10); (3) Those whose TCM syndrome differentiation belongs to the syndrome of dampness-heat and blood stasis obstruction; (4) Those aged between 18 and 65 years old; (5) Those who voluntarily participate in this clinical research and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Pregnant, lactating women, or those with a recent plan for childbearing; (2) Those with a severe allergic constitution and allergies to mesalazine or known components of traditional Chinese medicine; (3) Those with combined severe primary diseases such as severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, and hematopoietic system disorders; (4) Those with ulcerative colitis having severe complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon, rectal cancer, etc.; (5) Patients with mental disorders or intellectual disabilities; (6) Patients who have participated in other drug clinical studies within the recent 3 months; (7) Patients who are undergoing other treatment regimens for ulcerative colitis in addition to mesalazine treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculate the effective rate and remission rate of drug treatment after 8 weeks based on the improved Mayo scoring criteria; | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic response rate;TCM syndrome score;quality of life score;Mucosal healing rate;??????; | — |
Countries
china
Contacts
Public ContactFeng Peimin
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed