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
70 participants
INTERVENTIONAL
2025-05-30
2026-12-20
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, n =35: 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.
Nitazoxanide group
Nitazoxanide group, n= 35: will receive 1 g mesalamine three times daily plus nitazoxanide 500 mg twice 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.
Nitazoxanide
Nitazoxanide is an FDA-approved oral medication used to treat protozoal infections and is also effective against metronidazole-resistant Clostridium difficile colitis.
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.
Nitazoxanide
Nitazoxanide is an FDA-approved oral medication used to treat protozoal infections and is also effective against metronidazole-resistant Clostridium difficile colitis.
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
65 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
Clinical pharmacist
Locations
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Alexandria University
Alexandria, , Egypt
Countries
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Facility Contacts
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Other Identifiers
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4444
Identifier Type: -
Identifier Source: org_study_id
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