drugset / Trial / NCT02442960
Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Indigo naturalis | Traditional medicine (herbal / TCM) | 250 mg | Oral |
| Comparator | Indigo naturalis | Traditional medicine (herbal / TCM) | 750 mg | Oral |