ulcertive colitis
Conditions
Interventions
administration of one indigo naturalis FC enteric-coated tablet (including 0.5g indigo naturalis per tablet)twice a day for 4 weeks
Sponsors
Kanai Takanori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who are applied to the diagnostic criteria of ulcerative colitis (UC). 2)Patients with steroid-dependent or steroid-refractory active UC, or with active UC who are refractory to at least one of the other conventional therapies(tacrolimus,biological products, and low molecular weight compound) 3)Patients with 4 points or more Mayo score and 1 point or more endoscopic Mayo score. 4)16-year-old or older patients who agreed to this trial, and when patients who are younger than 20 years old, their legal representatives also have to agree to the trial.
Exclusion criteria
Exclusion criteria: 1.Patients who are clinically classified into severe or fulminant condition or have other conditions besides UC,such as infectious enteritis and so on. 2.Patients with symptomatic stenosis. 3.Patients who are planned to undergo surgery or patients who have experienced adverse effect or allergy of herbal medicines, and patients who have had herbal medicine which contains IN. 4. Patients with severe infection, severe heart disease,2.0 mg per dl or higher serum creatinine levels, 50IU per l or higher serum AST and ALT levels, malignant tumor or its previous history. 5.Patients who have possibility of pregnancy, or patients in nursing, or patients who hope to get pregnant. 6.Patients who are decided to be inappropriate for other reason by attending doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of clinical remission at 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical remission rate at week 24 2. Mayo score at week 8 and 24 3. Rate of Mayo endoscopic score of 0 at week 8 and 24 4. Partial Mayo score at week 8 and 24 5. Lichtiger score at week 4, 8, and 24 6. Electrocardiographic, chest X-ray, and echocardiographic findings before and after drug administration 7. Safety during the trial period | — |
Contacts
Public ContactYusuke Yoshimatsu
Keio University Hospital
Outcome results
None listed