Evaluating Safety and Efficacy of Herbal Treatment in 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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Herbal treatment (SA100)
Eligibility
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.
Ages Eligible for Study
13 Years - 75 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.