drugset / Trial / NCT02442960

Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis

NCT02442960

Phase 1 Completed 15 enrolled Stanford University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a 12-week, open-label, dose-escalation Phase 1b study of a herbal treatment given orally to subjects with ulcerative colitis. Subjects will be sequentially enrolled to one of two cohorts in up to two clinical sites. Treatment will be given for 8 weeks and study duration will be 12 weeks.

Timeline

Start
2014-12
Primary completion
2017-07-26
Completion
2017-07-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Indigo naturalis Traditional medicine (herbal / TCM) 250 mg Oral
Comparator Indigo naturalis Traditional medicine (herbal / TCM) 750 mg Oral

Indications