Study Results
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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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-07-15
2026-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
control group (Mesalamine group) who will receive 1 g mesalamine three times daily for 3 months.
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.
Rupatadine
(Rupatadine group) will receive 1 g mesalamine three times daily plus 20 mg rupatadine once daily for 3 months.
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.
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
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.
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
Eligibility Criteria
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Inclusion Criteria
* Both male and female will be included
* Mild and moderate UC patients are already diagnosed and confirmed by endoscope and histopathology.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Prof. Dr. Ahmed Ibrahim Mohammed El Mallah, faculty of pharmacy, Alexandria University.
UNKNOWN
Assoc. Prof. Dr. Noha Alaa Eldin Hassan Hamdy, Faculty of pharmacy, Alexandria University.
UNKNOWN
Assoc. Prof. Dr. Ibrahim Fathi Amer, Faculty of Medecine, Kafr Elsheikh University.
UNKNOWN
Alexandria University
OTHER
Responsible Party
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Reham ELshafeiy
Associate lecturer of clinical pharmacy
Locations
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Alexandria University
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5555
Identifier Type: -
Identifier Source: org_study_id
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