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NCT Number: NCT07333716

Desloratadine 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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Menofia university Hospitals

Shibīn al Kawm, Menofia, 32511, Egypt

Location status: Recruiting

Location contact

Menofia university Hospitals

CONTACT

[email protected]

+20 48 222 8304

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

desloratadine

Drug

mesalamine 1000 mg three times daily plus desloratadine 5 mg once daily for 3 months.

Mesalamine

Drug

mesalamine 1000 mg three times daily for 3 months

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Romisaa R Abd Alnapy

CONTACT

[email protected]

+201288667650

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Acronym: UC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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