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Investigating the Anti-inflammatory Effects of Frondanol in Adults With Inflammatory Bowel Disease

NCT05194007 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-11-20

No results posted yet for this study

Summary

This is a pilot, prospective, double-blinded, two-arm, randomized controlled trial of the efficacy of Frondanol in comparison to placebo in decreasing bowel inflammation in patients with a clinical diagnosis of inflammatory bowel disease who are in remission and on standard of care treatment.

Conditions

  • Ulcerative Colitis Chronic Mild
  • Ulcerative Colitis Chronic Moderate
  • Crohn Colitis

Interventions

DRUG

Frondanol

Frondanol capsule (1000 mg) will be administered orally (Twice daily) in the double blind settings

DRUG

Placebo

Placebo (corn starch) capsule will be administered orally (Twice daily) in the double blind settings

Sponsors & Collaborators

  • Mediclinic Middle East

    collaborator INDUSTRY

  • Rashid Hospital

    collaborator OTHER_GOV

  • Dubai Health Authority

    collaborator OTHER_GOV

  • Mohammed Bin Rashid University of Medicine and Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-19
Primary Completion
2024-11-19
Completion
2024-11-19

Countries

  • United Arab Emirates

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05194007 on ClinicalTrials.gov