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Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis

Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis - Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017359
Enrollment
20
Registered
2015-05-01
Start date
2015-05-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis

Interventions

Oral administration of Indigo naturalis 2g/day, 4 weeks

Sponsors

Osaka University, Graduate School of Medicine, Department of Gastroenterology and Hepatology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with ulcerative colitis 2)Patients older than 20 years old 3)Patients with moderate to severe activity 4)Patients resistant to the existing therapy with 5-aminosalicylate, corticosteroids, or other drugs for ulcerative colitis 5)Patients with no change of drugs for at least 2 weeks before the enter to this study 6)Patients had not taken Indigo naturalis for 1 month before enrolling to this study

Exclusion criteria

Exclusion criteria: 1)Patients with pregnancy or breastfeeding 2)Patients with mental illness 3)Patients with a disorder of liver or kidney 4)Patients taking antithrombotic or anticoagulant drugs, and patients with thrombocytopenia 5)Patients judged as inappropriate for the study because of their conditions

Design outcomes

Primary

MeasureTime frame
The existence of adverse effect

Secondary

MeasureTime frame
Clinical improvement rate Improvement of the endoscopic findings

Countries

Japan

Contacts

Public ContactHideki Iijima

Osaka University, Graduate School of Medicine Department of Gastroenterology and Hepatology

hiijima@gh.med.osaka-u.ac.jp06-6879-3621

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026