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Recruiting NCT07064707

Rupatadine in Patients With Ulcerative Colitis

Phase II Interventional Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mesalamine, Rupatadine.
Who it may be relevant to
Registry conditions: Ulcerative Colitis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Study to Evaluate Safety and Efficacy of Rupatadine in Patients With Ulcerative Colitis.

Overview

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

Interventions

  • Drug 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.
  • 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

Primary outcome measures

  • change in partial mayo score [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Alexandria University — Alexandria

Identifiers

NCT: NCT07064707 · 5555

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗