A Single Centre Prospective Randomized Double Blinded Trial to Assess the Efficiency of A Chinese Herbal-medicine (Xilei San) Suppository for Active Ulcerative Proctitis
Phase 2
- Conditions
- lcerative colitis (Proctitis type)
- Registration Number
- JPRN-UMIN000004401
- Lead Sponsor
- Hyogo College of Medicine, Department of Internal medicine, Division of Lower GI disease
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1.A patient who has had hypersensitivity to Chinese medicine. 2.A patient who has had an episode of severe hypersensitivity to food. 3.A patient who has complicated severe heart, kidney, respiratory, and metabolic disease. 4.A patient, who is pregnant, may be pregnant, breast-feeds or hopes to be pregnant in the study period. 5.A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission rate at 24 weeks after the start of protocol treatment (Full Analysis Set; Discontinuation of protocol treatment is accounted to be non-remission.)
- Secondary Outcome Measures
Name Time Method Evaluation of efficiency: Remission ratios at 48 weeks after start of protocol treatment, Ratio of the protocol continuation, Clinical activity in both the Rachmilewitz clinical activity index (CAI) and Endoscopic index (EI), Liley histological score, and evaluation of patients QOL using IBDQ, etc. Evaluation of safety: Adverse event, Abnormal values in blood test, etc.