ulcerative proctitis
Conditions
Interventions
Qingchang suppository group:Qingchang suppository + SASP suppository mimics
SASP suppository group:SASP suppository+Qingchang suppository mimics
Sponsors
Longhua hospital affiliated to Shanghai university of traditional Chinese medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. active mild/moderate ulcerative proctitis; 2. TCM syndrome of dampness-heat in large intestine; 3. Aged 18-65 years old; 4. Agree and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Ulcerative colitis extending to the segments beyond rectum; 2. Severe active ulcerative proctitis; 3. With the complications such as intestinal obstruction, intestinal perforation, massive hemorrhage of lower digestive tract, and periannal diseases; 4. With the history of intestinal resection; 5. Accompanied with manifestations outside colons, such as skin manifestation (oral ulcers, erythema nodosum and pyoderma gangrenosum), joint damage (such as peripheral arthritis, spinal arthritis), ocular lesions (such as iris inflammation, scleritis, uveitis), hepatobiliary disease (such as fatty liver, primary sclerosing cholangitis, cholelithiasis, thromboembolic disease etc.); 6. Confirmed or suspected bacterial dysentery, amebic dysentery, intestinal schistosomiasis, intestinal tuberculosis, fungal colitis, antibiotic associated colitis, eosinophilic colitis, Behcet's disease, Crohn's disease, ischemic colitis, radioactive enteritis, diverticulitis of colon and colorectal cancer; 7. With the history of using agents for treating ulcerative colitis, such as sulfasalazine, corticosteroids or immunosuppressive agents in the past 1 months; 8. Accompanied with severe primary cardiovascular disease, cerebrovascular disease, blood system disease and mental disease; 9. Serum creatine > the upper limit of normal value, ALT, AST, serum total bilirubin, AKP or gamma-GTP > the upper limit of normal value; 10. Infected with HIV, HBV or HCV; 11. With a history of diseases might influencing the clinical trial, such as malignant disease, hemorrhagic disease, active gastric ulcer or duodenal ulcer, autoimmune disease or emotional disorder; 12. Women in pregnant, lactating or planning a pregancy; 13. With a history of allergy in salicylic acid preparation or composition of Qingchang Suppository; 14. Suspected alcohol abuse, drug abuse history; 15. Patients participating in other clinical trials within previous 3 months; 16. With the factors or the conditions which might decrease the probability of recruitment or complicate the recruitment judged by the researchers, such as unstable working environment, mental disorders, difficulties in communication, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ESR;CRP;efficacy rate of TCM symptoms;efficacy rate of colonscopy;efficacy rate of pathology examination of rectum mucosa; | — |
Countries
China
Contacts
Public ContactLIN Jiang
Longhua hospital affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed