Ulcerative colitis
Conditions
Interventions
Qing-Dai (2g daily) for 8 weeks
Qing-Dai (1g daily) for 8 weeks
Qing-Dai (0.5g daily) for 8 weeks
Placebo for 8 weeks
Sponsors
School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Patients who fullfil diagnostic criteria of ulcerative colitis 2 Patients with Mayo score of at least 6 and Mayo endoscopic score of at least 2 3 Patients are at least 16 years of age 4 Written consent is obtained from patients (from legal guardian if patient's age< 20 years old
Exclusion criteria
Exclusion criteria: 1 Patients with severe or fulminate activity 2 Patients with proctitis 3 Patients who have signs of other types of colitis 4 Patients with symptomatic GI stenosis 5 The doctor have a plan to conduct colectomy 6 Patients with a history of side effect or allergy of Chinese herbal medicine, or with previous usage of medication including Qing Dai for ulcerative colitis 7 Patients who have severe infection 8 Patients who have severe heart disease 9 Patients with serum creatinine level of at least 2.0 mg/dL 10 Patients with total bilirubin level of at least 2.0 mg/dL or with ALT/AST levels of at least 50IU/l 11 Patients with a history of malignant diseases 12 Patients with apparent pshycological disorders 13 Pregnant patients, or patients who breast feed to baby or patients who conceive conception 14 Doctor judges inadequate patients to be enrolled into the clinical trial 15 Exclusion criteria of concomittent medication: Changing the dose of mesalamine within 1 week before the commencement of the study was not allowed. The patients were not treated with topical mesalamine/steroid within 1 week before the commencement of the study. The patients were not treated with leukocytapheresis, prednisolone > 40 mg, tacrolimus, cyclosporine, or Chinese herbal medicine within 2 weeks before the commencement of the study. Concomitant treatment with thiopurine, started more than 4 weeks before the commencement of the study, was allowed if that dosage had been stable for at least 4 weeks before the study was conducted. The patients were not treated with adalimumab within 4 weeks or infliximab within 8 weeks before the commencement of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of clinical response at week 8 (defined as decrease in the Mayo score of at least 3 points and a decrease of at least 30% from the baseline score, with a decrease of at least 1 point on the rectal bleeding subscore or an absolute rectal bleeding subscore of 0 or 1.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rates of clinical remission at week 8 2) Changes of the Mayo score between baseline and week 8 3) Rates of endoscopic remission at week 8 4) Changes of the partial Mayo score between baseline and week 4 or week 8 5) Changes of Lichtiger score between baseline and week 4 or week 8 6) Changes of quantitative fecal blood test between baseline and week 8 7) significance of fecal calprotectin level between baseline and week 8 Before we finished to fix the data, some following items of secondary endpoints were added 1) Changes of the CRP, serum ALB between baseline and week2 or, week 4,or week 8 2) Changes of the partial Mayo score, Lichtiger score between baseline and week 2 3) The rate of patients whose quantitative fecal blood test was less than 100 was compared among each group. 4) The rate of patients whose fecal calprotectin test was less than 100 was compared among each group. | — |
Countries
Japan
Contacts
Public ContactMakoto Naganuma
School of Medicine, Keio University Department of Gastroenterology and Hematology
Outcome results
None listed