Rupatadine in Patients With Ulcerative Colitis

NCT ID: NCT07064707

Last Updated: 2025-11-19

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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-10-21

Brief Summary

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Ulcerative colitis (UC) is a chronic inflammatory condition that primarily targets the large intestine. Although substantial progress has been made in treatment modalities-especially with the development of immunomodulatory drugs and biologic therapies-managing UC continues to present significant challenges. At present, there is no definitive cure, and current treatment strategies are largely focused on controlling inflammation, relieving symptoms, and halting disease progression

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

control group (Mesalamine group) who will receive 1 g mesalamine three times daily for 3 months.

Group Type ACTIVE_COMPARATOR

Mesalamine

Intervention Type DRUG

Mesalamine or 5-amino salicylic acid (5-ASA), plays a crucial role in the treatment of ulcerative colitis (UC). It is the first-line therapy for mild to moderate cases of UC and is considered a cornerstone in its management.

Rupatadine

(Rupatadine group) will receive 1 g mesalamine three times daily plus 20 mg rupatadine once daily for 3 months.

Group Type ACTIVE_COMPARATOR

Mesalamine

Intervention Type DRUG

Mesalamine or 5-amino salicylic acid (5-ASA), plays a crucial role in the treatment of ulcerative colitis (UC). It is the first-line therapy for mild to moderate cases of UC and is considered a cornerstone in its management.

Rupatadine

Intervention Type DRUG

Rupatadine, a dual histamine H1 receptor and platelet-activating factor (PAF) receptor antagonist, has shown promising anti-inflammatory effects beyond its conventional use in allergic conditions

Interventions

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Mesalamine

Mesalamine or 5-amino salicylic acid (5-ASA), plays a crucial role in the treatment of ulcerative colitis (UC). It is the first-line therapy for mild to moderate cases of UC and is considered a cornerstone in its management.

Intervention Type DRUG

Rupatadine

Rupatadine, a dual histamine H1 receptor and platelet-activating factor (PAF) receptor antagonist, has shown promising anti-inflammatory effects beyond its conventional use in allergic conditions

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Both male and female will be included
* Mild and moderate UC patients are already diagnosed and confirmed by endoscope and histopathology.

Exclusion Criteria

* Breast feeding or pregnancy.
* Colorectal cancer patients.
* Patients with severe UC.
* Patients taking rectal or systemic steroids.
* Patients taking immunosuppressives or biological therapies.
* Addiction to alcohol and / or drugs.
* Known allergy to the studied medications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Ahmed Ibrahim Mohammed El Mallah, faculty of pharmacy, Alexandria University.

UNKNOWN

Sponsor Role collaborator

Assoc. Prof. Dr. Noha Alaa Eldin Hassan Hamdy, Faculty of pharmacy, Alexandria University.

UNKNOWN

Sponsor Role collaborator

Assoc. Prof. Dr. Ibrahim Fathi Amer, Faculty of Medecine, Kafr Elsheikh University.

UNKNOWN

Sponsor Role collaborator

Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Reham ELshafeiy

Associate lecturer of clinical pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alexandria University

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Reham Elshafiey, PhD

Role: CONTACT

01025465180

Facility Contacts

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Reham Elshafiey, PhD

Role: primary

01025465180

Other Identifiers

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5555

Identifier Type: -

Identifier Source: org_study_id

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