Rupatadine in Patients With Ulcerative Colitis

Sponsor
Alexandria University
Study ID
NCT07064707
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Mesalamine — 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 — 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

Study Details

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

Key Dates

First listed
Jul 15, 2025
Start date
Jul 15, 2025
Status verified
Nov 2025
Primary completion
Jul 15, 2026
Completion
Oct 21, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    control group (Mesalamine group) who will receive 1 g mesalamine three times daily for 3 months.
  • Active Comparator: Rupatadine
    (Rupatadine group) will receive 1 g mesalamine three times daily plus 20 mg rupatadine once daily for 3 months.

Primary Outcome Measure

change in partial mayo score [ Time Frame: 3 months ]

Central Contacts

Find similar trials

Nationwide
Ulcerative colitis trialsGastroenterology trialsInflammatory bowel disease trialsAutoimmune disease trials

Related Studies