IN for practical use

Phase 3

Recruiting

• Conditions: ulcertive colitis

• Registration Number: JPRN-jRCTs031190156
• Lead Sponsor: Kanai Takanori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified