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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | Herbal treatment (SA100) 500 mg/day (250 mg twice per day) |
|
| Cohort 2 | Active Comparator | Herbal treatment (SA100) 1.5 g/day (750 mg twice per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbal treatment (SA100) | Drug | This treatment has been used extensively in traditional medicine practices for hundreds of years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of herbal treatment (SA100) as assessed by clinical and laboratory adverse events. | To evaluate the safety and tolerability of oral SA100 given twice daily for 8 weeks, as assessed by clinical and laboratory adverse events. | Up to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Mayo Score | To evaluate preliminary efficacy (clinical response and remission rates) of oral SA100 based on (a) accepted disease activity and laboratory measures, including visual and histopathologic assessment of the colon by endoscopy, and (b) changes in serum biomarkers. | Screening/Baseline, Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berkeley Limketkai, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94306 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34969665 | Derived | Saiki JP, Andreasson JO, Grimes KV, Frumkin LR, Sanjines E, Davidson MG, Park KT, Limketkai B. Treatment-refractory ulcerative colitis responsive to indigo naturalis. BMJ Open Gastroenterol. 2021 Dec;8(1):e000813. doi: 10.1136/bmjgast-2021-000813. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) |
To evaluate preliminary efficacy (clinical response and remission rates) of oral SA100 based on (a) accepted disease activity and laboratory measures, including visual and histopathologic assessment of the colon by endoscopy, and (b) changes in serum biomarkers. |
| Screening/Baseline, Week 2, 4, 6, 8, 10, 12 |
| Biomarker levels (CRP & ESR) | To evaluate preliminary efficacy (clinical response and remission rates) of oral SA100 based on (a) accepted disease activity and laboratory measures, including visual and histopathologic assessment of the colon by endoscopy, and (b) changes in serum biomarkers. | Screening/Baseline, Week 8 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |