Desloratadine in Patients With Ulcerative Colitis (UC)

January 27, 2026 updated by: Romisaa Raafat Abd Alnapy Mohamed, Tanta University

Efficacy and Safety of Desloratadine as Adjuvant Therapy in Patients With Ulcerative Colitis

The purpose of this study is to investigate safety and therapeutic efficacy of antihistamine (desloratadine) on inflammation and disease activity when administered as adjuvant therapies with the traditional therapy 5-aminosalisylic acid (mesalamine) in patients with mild to moderate ulcerative colitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ulcerative colitis is a chronic inflammatory autoimmune disease affecting the colon. The World Health Organization has classified it as a relatively new treatment-resistant disease, and its prevalence has reportedly increased significantly in Egypt. A preclinical study was conducted to evaluate desloratadine as a potential therapeutic agent for ulcerative colitis, based on its known anti-inflammatory and antioxidant properties. The study concluded that desloratadine effectively alleviated experimental ulcerative colitis. This positive effect is attributed to its anti-inflammatory and antioxidant properties, which work by regulating mast cell activity and inhibiting histamine release.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Menofia
      • Shibīn al Kawm, Menofia, Egypt, 32511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Both male and female sex.
  • patients with age ranged from 18 to 65.
  • patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline.
  • Patients treated with 5-aminosalisylic acid (mesalamine).

Exclusion Criteria:

  • Patients with severe UC
  • Significant liver or kidney function abnormalities
  • Pregnant or lactating females
  • Treatment with systemic or rectal steroids
  • Treatment with immunosuppressant or biological therapies
  • Known allergy to desloratadine or any ingredient in the formulation
  • Patients with other inflammatory diseases
  • Patients with history of colon cancer
  • Patients with complete or partial colectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group I (Control group)
which will receive mesalamine (standard treatment ) 1000 mg three times daily for 3 months and serve as the control group
Drug: mesalamine
mesalamine 1000 mg three times daily for 3 months
Active Comparator: Group II (Desloratadine group)
which will receive mesalamine (standard treatment )1000 mg three times daily plus desloratadine 5 mg once daily for 3 months
Drug: Desloratadine
mesalamine 1000 mg three times daily plus desloratadine 5 mg once daily for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in disease activity and severity
Time Frame: over a 3 month follow -up period
Change in disease activity and severity through Partial Mayo Scoring Index (PMSI) and Truelove and Witt's classification
over a 3 month follow -up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum biomarkers
Time Frame: Change from baseline in serum biomarker over 3 months
Change in serum biomarkers of inflammation and oxidative stress (TNF-α & MDA)
Change from baseline in serum biomarker over 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Romisaa R Abd Alnapy, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 1, 2026

First Submitted That Met QC Criteria

January 1, 2026

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/2025 TRop1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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