ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02442960
Recruitment Status : Unknown
Verified May 2016 by Berkeley Limketkai, Stanford University.
Recruitment status was:  Recruiting
First Posted : May 13, 2015
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Berkeley Limketkai, Stanford University

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Herbal treatment (SA100) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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-to-Moderate Ulcerative Colitis
Study Start Date : September 2014
Estimated Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cohort 1
Herbal treatment (SA100) 500 mg/day (250 mg twice per day)
Drug: Herbal treatment (SA100)
This treatment has been used extensively in traditional medicine practices for hundreds of years.

Active Comparator: Cohort 2
Herbal treatment (SA100) 1.5 g/day (750 mg twice per day)
Drug: Herbal treatment (SA100)
This treatment has been used extensively in traditional medicine practices for hundreds of years.




Primary Outcome Measures :
  1. Safety and tolerability of herbal treatment (SA100) as assessed by clinical and laboratory adverse events. [ Time Frame: Up to 12 Weeks ]

Secondary Outcome Measures :
  1. Mayo Score [ Time Frame: Screening/Baseline, Week 8 ]
  2. Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: Screening/Baseline, Week 2, 4, 6, 8 ]
  3. Biomarker levels [ Time Frame: Screening/Baseline, Week 2, 4, 8 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Age ≥ 18 years and ≤ 75 years.
  2. Mild-to-moderate ulcerative colitis (biopsy-proven).
  3. Mayo Scoring System Assessment of Ulcerative Colitis Activity score of 3 to 10 at screening.
  4. Patients with active disease who are refractory to, intolerant to, or unwilling to take 5-aminosalicylic acid (5-ASA).
  5. Physician's Global Assessment (PGA) Mayo subscore of at least 1 at screening.
  6. Mayo rectal bleeding 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442960


Contacts
Contact: Ali Al-Rajhi, Ph.D. 650 721 4284 alrajhi@stanford.edu

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94306
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Berkeley Limketkai, MD Stanford University

Responsible Party: Berkeley Limketkai, Dr. Berkeley Limketkai, Stanford University
ClinicalTrials.gov Identifier: NCT02442960     History of Changes
Other Study ID Numbers: 30934
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases