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Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis — SA100  

Ulcerative Colitis Clinical Trial

Official title:
An Open-Label, Dose-Escalation Phase Ib Study Evaluating the Safety and Preliminary Efficacy of Oral SA100 in the Treatment of Patients With Mild, Moderate or Severe Ulcerative Colitis

Clinical Trial 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.

Clinical Trial Description

This study consists of a 3-month period (12 weeks). You will receive study drug (SA100) for a 2-month period (8weeks) and then will continue to receive study assessements for an additional 1 month (4weeks). During the period in which you receive study drug (SA100), you will be asked to take the study drug twice a day (once in the morning and once in the evening), preferably at the same time each day. You will be assigned to one of three possible treatment groups. The three possible treatment groups are SA100 250 mg, 500 mg, or 750 mg. The group you are assigned to at the start of the study will remain the same throughout the study. Blood samples, stool (feces), and tissue biopsies (up to 3 per region of colon) will be collected for testing purposes. These samples may also be kept for several years for future research. An electrocardigram (ECG, which measures the electrical activity in your heart) will be taken at screening and week 2; and a flexible sigmoidoscopy will be performed at screening and week 8, (flexible tube that visualizes your intestine/colon and allows for tissue and stool to be obtained) to confirm your diagnosis of ulcerative colitis, to assess the severity of your disease, and for future testing of your tissue. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02442960
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase Phase 1
Start date December 2014
Completion date July 26, 2017
View Details
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