Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis

NCT02442960 | Completed Phase 1

• 1 other identifier: 30934
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Total Mayo Score

  Screening/Baseline, Week 8

• Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  Screening/Baseline, Week 2, 4, 6, 8, 10, 12

• Biomarker levels (CRP & ESR)

  Screening/Baseline, Week 8

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

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

Drug: Herbal treatment (SA100)

Cohort 2

ACTIVE COMPARATOR

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

Drug: Herbal treatment (SA100)

Interventions

Herbal treatment (SA100) DRUG

This treatment has been used extensively in traditional medicine practices for hundreds of years.

Also known as: SA100

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 13 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94306, United States

Location

Related Publications (1)

• 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.

  PMID: 34969665 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Berkeley Limketkai, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 13, 2015
• Study Start: December 1, 2014
• Primary Completion: July 26, 2017
• Study Completion: July 26, 2017
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

US (1)