CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 13 enrolled
Drug / intervention
Frondanol +1 moredrug
Likely dose
Frondanol 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05194007
NCT05194007Phase 3Completed
CompareCT.gov

A Pilot Randomized, Double-blind, Placebo-controlled Trial to Investigate the Anti-inflammatory Effects of Frondanol in Adults With Inflammatory Bowel Disease

Mohammed Bin Rashid University of Medicine and Health Sciences·interventional·Posted Jan 18, 2022·Updated Nov 20, 2024

In Brief

A Phase 3 clinical trial evaluating Frondanol and Placebo for Ulcerative Colitis Chronic Mild and 2 related conditions. Completed, enrolled 13 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate, Crohn Colitis
CountriesUnited Arab Emirates
CollaboratorsMediclinic Middle East, Rashid Hospital, Dubai Health Authority

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJan 18, 2022
Enrollment StartFeb 19, 2022
Primary CompletionNov 19, 2024
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 4.5 years ago

Interventions

Frondanoldrug

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

Placebodrug

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