Ulcerative Colitis Clinical Trial
Official title:
Clinical Study Evaluating the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis Treated With Mesalamine
This is a randomized, controlled study evaluating diosmin tablets administered daily for 3 months. The purpose of the study is to evaluate the efficacy and safety of diosmin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using modified truelove and witt's classification.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | November 2024 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years old. - Both male and female sex. - Newly diagnosed patients with mild and moderate ulcerative colitis and treated with 5-aminosalicylic acid (mesalamine). Exclusion Criteria: - Patients with severe ulcerative colitis. - Patients with colorectal cancer. - Patients on rectal or systemic steroids. - Patients on immunosuppressants or biological therapies. - Patients with previously failed treatment with sulphasalazine. - Patients with known allergy to study medications. - History of complete or partial colectomy. - Patients with heart diseases and arrhythmia. - Patients on blood thinning agents. - Patients on anticoagulants (warfarin), anticonvulsants (carbamazepine and phenytoin), muscle relaxants (chlorzoxazone) and non-steroidal anti-inflammatory drugs (diclofenac). |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta university hospital | Tanta |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the change in Truelove and Witt's classification. | at baseline then after 3 months | ||
Primary | the change in health related quality of life (HRQoL) questionnaire | at baseline then after 3 months | ||
Secondary | the change in the measured biological parameters (TNF alpha, MDA, caspase-3) | at baseline then after 3 months |
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