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Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis (SA100)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Herbal treatment (SA100)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 13 years and ≤ 75 years.
  2. Mild, moderate and severe ulcerative colitis (biopsy-proven)
  3. Mayo Scoring System Assessment of Ulcerative Colitis Activity score of 3 to 12 at screening.
  4. Patients with active disease who are refractory to, intolerant to, or unwilling to take 5-aminosalicylic acid (5-ASA).
  5. 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.
  6. Physician's Global Assessment (PGA) Mayo subscore of at least 1 at screening.
  7. Endoscopic evidence of active mucosal disease as assessed by flexible sigmoidoscopy with Mayo mucosal appearance subscore of at least 1 at screening.
  8. 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.
  9. 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.
  10. Ability to adhere to the study visit schedule and other protocol requirements.
  11. Adequate cardiac, renal, and hepatic function as determined by the principal investigators.
  12. Written informed consent will be obtained before any study procedure is performed.

Exclusion Criteria:

  1. Are nursing or pregnant.
  2. Patients who are in critical condition
  3. Crohn's disease or indeterminate colitis.
  4. Known sensitivity to any ingredients in the study drug.
  5. A change in therapy within 2 weeks before the baseline visit.
  6. Use of immunomodulators (cyclosporine, mercaptopurine, azathioprine, etc.).
  7. Diagnosis of diabetes, heart failure, unstable angina, liver or kidney disease, or any other unstable medical condition.
  8. Any clinically meaningful laboratory abnormality that in the judgment of the investigator should preclude participation in the study.
  9. Impaired renal function (serum creatinine levels >2.0 mg/dL) at screening.
  10. Alanine transaminase (ALT) or aspartate transaminase (AST) laboratory values >1.5 times upper limit of normal at screening.
  11. Diagnosis of Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli in stool.
  12. Positive test for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg) at screening.
  13. Active malignancy (except basal cell carcinoma).
  14. Active alcohol or drug abuse.
  15. Tobacco smoking within 2 weeks before study entry.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cohort 1

Cohort 2

Arm Description

Herbal treatment (SA100) 500 mg/day (250 mg twice per day)

Herbal treatment (SA100) 1.5 g/day (750 mg twice per day)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 23, 2015
Last Updated
November 4, 2020
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02442960
Brief Title
Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis
Acronym
SA100
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
July 26, 2017 (Actual)
Study Completion Date
July 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Active Comparator
Arm Description
Herbal treatment (SA100) 500 mg/day (250 mg twice per day)
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
Herbal treatment (SA100) 1.5 g/day (750 mg twice per day)
Intervention Type
Drug
Intervention Name(s)
Herbal treatment (SA100)
Other Intervention Name(s)
SA100
Intervention Description
This treatment has been used extensively in traditional medicine practices for hundreds of years.
Primary Outcome Measure Information:
Title
Safety and tolerability of herbal treatment (SA100) as assessed by clinical and laboratory adverse events.
Description
To evaluate the safety and tolerability of oral SA100 given twice daily for 8 weeks, as assessed by clinical and laboratory adverse events.
Time Frame
Up to 12 Weeks
Secondary Outcome Measure Information:
Title
Total Mayo Score
Description
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.
Time Frame
Screening/Baseline, Week 8
Title
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Description
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.
Time Frame
Screening/Baseline, Week 2, 4, 6, 8, 10, 12
Title
Biomarker levels (CRP & ESR)
Description
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.
Time Frame
Screening/Baseline, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berkeley Limketkai, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34969665
Citation
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.
Results Reference
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Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis

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