Ulcerative colitis (Proctitis type)
Conditions
Interventions
Placebo arm: A sham suppository containing 0.1g of medical carbon during the study period (for 48 weeks).
True arm: A suppository containing 0.1g of Herbal-medicine (Xilei San) during the study pe
Sponsors
Hyogo College of Medicine, Department of Internal medicine, Division of Lower GI disease
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A patient who is diagnosed as ulcerative colitis. 2. A patient who has been diagnosed as active UC with disease extension of within 15cm from anus by either endoscopic or roentgenogram examination within 4 weeks. 3. A patient who refracted more than 4 weeks of conventional topical therapy prior to enroll the trial. 4. A patient who is expected to suffer from severe adverse effect of the conventional therapy, i.e. 5-ASA and/or steroid, by reason of his (her) past history or other. (judged by a doctor in charge) 5. A patient who is 16 to 64 years old and has written his (her) signature to a document for agreement. (If a patient is under 20 years old, a signature of his (her) legal representative is necessary.)
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKen Fukunaga
Hyogo College of Medicine Lower GI disease
Outcome results
None listed