Ulcerative ColitisPhase 1SA100NCT02442960
Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis
A Phase 1 study testing Herbal treatment (SA100) in people with Ulcerative Colitis, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Herbal treatment (SA100)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 26 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 13 years and ≤ 75 years.
- Mild, moderate and severe ulcerative colitis (biopsy-proven)
- Mayo Scoring System Assessment of Ulcerative Colitis Activity score of 3 to 12 at screening.
- Patients with active disease who are refractory to, intolerant to, or unwilling to take 5-aminosalicylic acid (5-ASA).
- Patients of age ≥ 13 years and ≤ 17 years with active disease who are refractory or intolerant to 5-aminosalicyclic acid (5-ASA), corticosteroids, small molecule immunomodulators, and biologics or corticosteroid-dependent.
- Physician's Global Assessment (PGA) Mayo subscore of at least 1 at screening.
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- Endoscopic evidence of active mucosal disease as assessed by flexible sigmoidoscopy with Mayo mucosal appearance subscore of at least 1 at screening.
- Female patients of child-bearing potential must have a negative serum pregnancy test at the screening visit and agree to use two medically reliable methods of contraception (such as barrier with either spermicide or hormonal contraception) during the study period.
- Male patients must be willing to use acceptable contraceptive methods and assure that their female partners of child-bearing potential use acceptable contraceptive methods during the study period.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Adequate cardiac, renal, and hepatic function as determined by the principal investigators.
- Written informed consent will be obtained before any study procedure is performed.
Who cannot join
- Are nursing or pregnant.
- Patients who are in critical condition
- Crohn's disease or indeterminate colitis.
- Known sensitivity to any ingredients in the study drug.
- A change in therapy within 2 weeks before the baseline visit.
- Use of immunomodulators (cyclosporine, mercaptopurine, azathioprine, etc.).
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- Diagnosis of diabetes, heart failure, unstable angina, liver or kidney disease, or any other unstable medical condition.
- Any clinically meaningful laboratory abnormality that in the judgment of the investigator should preclude participation in the study.
- Impaired renal function (serum creatinine levels >2.0 mg/dL) at screening.
- Alanine transaminase (ALT) or aspartate transaminase (AST) laboratory values >1.5 times upper limit of normal at screening.
- Diagnosis of Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli in stool.
- Positive test for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg) at screening.
- Active malignancy (except basal cell carcinoma).
- Active alcohol or drug abuse.
- Tobacco smoking within 2 weeks before study entry.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Herbal treatment (SA100)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal treatment (SA100)Drug
Also called SA100
This treatment has been used extensively in traditional medicine practices for hundreds of years.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Herbal treatment (SA100) 500 mg/day (250 mg twice per day) Receives: Drug: Herbal treatment (SA100) |
| Cohort 2 | Active comparator | Herbal treatment (SA100) 1.5 g/day (750 mg twice per day) Receives: Drug: Herbal treatment (SA100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 Weeks
Secondary outcomes (3)
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.
Measured: Screening/Baseline, Week 8
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.
Measured: 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.
Measured: Screening/Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startDec 2014
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berkeley Limketkai, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442960
- Sponsor's protocol ID
- 30934
- Acronym
- SA100
- Status last verified
- Nov 2020
- First submitted
- 23 Apr 2015
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34969665
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02442960
- Acronym / sponsor ID
- SA100 / 30934
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: Herbal treatment (SA100)Herbal treatment (SA100) 500 mg/day (250 mg twice per day) |
| Cohort 2 | Active comparator | Drug: Herbal treatment (SA100)Herbal treatment (SA100) 1.5 g/day (750 mg twice per day) |
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 13 years and ≤ 75 years.
- Mild, moderate and severe ulcerative colitis (biopsy-proven)
- Mayo Scoring System Assessment of Ulcerative Colitis Activity score of 3 to 12 at screening.
- Patients with active disease who are refractory to, intolerant to, or unwilling to take 5-aminosalicylic acid (5-ASA).
- Patients of age ≥ 13 years and ≤ 17 years with active disease who are refractory or intolerant to 5-aminosalicyclic acid (5-ASA), corticosteroids, small molecule immunomodulators, and biologics or corticosteroid-dependent.
Key exclusion criteria (15 listed)
- Are nursing or pregnant.
- Patients who are in critical condition
- Crohn's disease or indeterminate colitis.
- Known sensitivity to any ingredients in the study drug.
- A change in therapy within 2 weeks before the baseline visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal treatment (SA100)Also: SA100This treatment has been used extensively in traditional medicine practices for hundreds of years. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Safety and tolerability of herbal treatment (SA100) as assessed by clinical and laboratory adverse events.
Time frame: Up to 12 Weeks
To evaluate the safety and tolerability of oral SA100 given twice daily for 8 weeks, as assessed by clinical and laboratory adverse events.
3 secondary outcomes
Total Mayo Score
Time frame: Screening/Baseline, Week 8
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: Screening/Baseline, Week 2, 4, 6, 8, 10, 12
Biomarker levels (CRP & ESR)
Time frame: Screening/Baseline, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 34969665Saiki 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berkeley Limketkai, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Herbal treatment (SA100) in people with Ulcerative Colitis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of herbal treatment (SA100) as assessed by clinical and laboratory adverse events. (time frame: Up to 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02442960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.