ulcerative colitis
Conditions
Interventions
administered with anal plug for 8 weeks
experimental group:Qingchang Suppositories
1 pill twice daily
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.active ulcerative colitis (mild to moderate) ; 2.the subjects between 18 and 80 years male or female; 3.the pregnancy test result of women of childbearing age is negative; 4.the subjects informed consent.
Exclusion criteria
Exclusion criteria: 1.ulcerative colitis involving intestinal segments other than the rectum. 2.severe ulcerative colitis in the active period. 3.patients with complications such as intestinal obstruction intestinal perforation massive hemorrhage of lower digestive tract or perianal diseases. 4.patients with previous bowel resection 5.extra-colonic manifestations such as skin and mucosal manifestations (oral ulcer nodular erythema and pyoderma gangrenosum) joint lesions (such as peripheral arthritis spinal arthritis etc.) eye lesions (such as iritis scleritis uveitis etc.) hepatobiliary diseases (such as fatty liver primary sclerosing cholangitis cholelithiasis etc.) thromboembolic disease. 6.confirmed or suspected bacillary dysentery amoebic dysentery intestinal schistosomiasis intestinal tuberculosis fungal colitis antibiotic-associated colitis eosinophilic colitis Behcet's disease Crohn's disease ischemic enteritis radiation enteritis undetermined colitis colonic diverticulitis colorectal cancer etc. 7.sulfasalazine hormone immunosuppressants and other drugs for treating ulcerative colitis were used in the past 1 month. 8.patients with severe primary cardiovascular cerebrovascular hematological diseases and psychiatric disorders 9.the upper limit of serum creatinine>normal reference value the upper limit of alanine aminotransferase aspartate aminotransferase serum total bilirubin alkaline phosphatase ?-glutamyl transferase>normal reference value. 10. patients known to be infected with the human immunodeficiency virus (HIV) hepatitis B virus (HBV) or hepatitis C virus (HCV). 11.those who have a medical history that may affect participation in the trial including malignant diseases bleeding diseases active gastric or duodenal ulcers autoimmune diseases or emotional disorders. 12. those who suspect or do have a history of alcohol or drug abuse. 13. allergic constitution history of allergy to salicylic acid preparation Qingchang Suppositories or any excipients. 14. pregnant or lactating women patients with recent fertility plans. 15. patients who have participated in clinical trials of other drugs in the past 3 months. 16. according to the researcher's judgment other diseases that may reduce the possibility of enrollment or complicate enrollment such as frequent changes in the working environment mental disorders communication difficulties etc which are not suitable to participate in this clincial trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate of ulcerative colitis; | — |
Secondary
| Measure | Time frame |
|---|---|
| interleukin 9 receptor;GAS6;c-reactive protein;Th9 cells;Clinical efficacy rate of ulcerative colitis;SIRPa;erythrocyte sedimentation rate;TCM Syndrome Score;colon mucosa specimen;interleukin-9;Transforming growth factor ß;fecal calprotectin;interleukin-4;colonscopy;spleen focus forming virus proviral integration oncogene; | — |
Countries
China
Contacts
Public ContactShan Jingyi
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed