Desloratadine in Patients With Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulcerative Colitis (UC) Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I (Control group)

which will receive mesalamine (standard treatment ) 1000 mg three times daily for 3 months and serve as the control group

Group Type PLACEBO_COMPARATOR

mesalamine

Intervention Type DRUG

mesalamine 1000 mg three times daily for 3 months

Group II (Desloratadine group)

which will receive mesalamine (standard treatment )1000 mg three times daily plus desloratadine 5 mg once daily for 3 months

Group Type ACTIVE_COMPARATOR

Desloratadine

Intervention Type DRUG

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

Interventions

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Desloratadine

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

Intervention Type DRUG

mesalamine

mesalamine 1000 mg three times daily for 3 months

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No