Ulcerative Colitis
Conditions
Brief summary
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
DRUGMesalamine
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.
DRUGRupatadine
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
Sponsors
Prof. Dr. Ahmed Ibrahim Mohammed El Mallah, faculty of pharmacy, Alexandria University.
Assoc. Prof. Dr. Noha Alaa Eldin Hassan Hamdy, Faculty of pharmacy, Alexandria University.
Assoc. Prof. Dr. Ibrahim Fathi Amer, Faculty of Medecine, Kafr Elsheikh University.
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in partial mayo score | 3 months | The Partial Mayo Score (PMS) index will be utilized to ascertain the degree of disease severity. One non-invasive clinical measure for determining the severity of UC is the PMS. The composite score is derived from three subcategories: stool frequency, rectal bleeding, and physician's general assessment. The total score falls between 0 and 9 |
Countries
Egypt
Contacts
Primary ContactReham Elshafiey, PhD
Outcome results
None listed