Ulcerative proctitis
Conditions
Interventions
experimental group :MAP treatment, qd
Sponsors
Hebei Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18–75 years (male or female). 2. Diagnosed with ulcerative proctitis before baseline, with a Mayo score of 6-10, diagnosed with moderate ulcerative proctitis during the screening period. 3. Stool frequency score >= 2, endoscopic score >= 2, rectal bleeding score >= 1 within 3 days before the first study medication. 4. Sigmoidoscopy confirmed that the lesion involved the sigmoid colon 15 cm and below. 5. Female subjects with fertility must have a negative blood pregnancy test result before enrolment and agree to take adequate contraceptive measures within 30 days from the beginning of the study to the end of the last study administration. 6. Subjects must voluntarily participate in this study.
Exclusion criteria
Exclusion criteria: 1. Subjects with diagnosis of uncertain colitis, NSAIDs-induced colitis, ischemic colitis, infectious colitis or Crohn's disease. 2. Subjects with a history of colectomy and colorectal surgery within 6 months before screening, or subjects who may need ulcerative colitis surgery during treatment. 3. Subjects with colorectal cancer. 4. Those with contraindications to colonoscopy and proctoscopy. 5. Severe allergies, including those with a history of allergies to research medical apparatus and accessories. 6. Subjects with hormone-dependent or hormone-resistant bowel disease. 7. Those who have used any immunomodulators/inhibitors within 60 days before screening. 8. Subjects with serious primary diseases and mental illnesses such as liver, kidney, hematopoietic system, endocrine system, etc. 9. Subjects with a history of smoking, alcohol, drug abuse and/or a positive drug screening test result (Morphine, Cannabis, Methamphetamine, Dimethylene Dioxyamphetamine, Ketamine). 10. Participated in >= 3 clinical trials of drugs or medical apparatus as subjects within 1 year before screening or participated in clinical trials of any drugs or medical apparatus within 1 month. 11. Organ dysfunction (such as liver and kidney dysfunction) found in physical examination, vital signs, electrocardiogram and clinical laboratory measurement, or any evidence of clinically significant deviation from normal values (beyond the scope consistent with the target population). 12. Women who are pregnant or breastfeeding. 13. Subjects who cannot fill in a diary card or cannot follow the data collection procedures. 14. Subjects with any other combined diseases that may increase the risk of toxicity according to the opinion of investigator. 15. Other situations that the investigator thinks it is not suitable to be selected for in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response;Mucosal Healing; | — |
Countries
China
Contacts
Public ContactGao Jihua
Hebei Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed