NCT05626166

the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis

Clinical Study Evaluating the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis Treated With Mesalamine

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study aims at evaluating the efficacy and safety of diosmin as add-on therapy to mesalamine in patients with mild to moderate ulcerative colitis. This proof of concept study will be designed to be a randomized, double-blind, placebo controlled parallel study. The study will be conducted on 60 patients with mild to moderate ulcerative colitis receiving mesalamine. The patient will be followed for 3 months. The patients will be randomised into the following two groups: Group I (Control group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo tablets twice daily for 3 months. Group II: (Diosmin group; n=30) which will receive mesalamine 1000 mg three times daily plus diosmin 600 mg twice daily for 3 months. All participants included in this study will be subjected to the following: 1. Demography, history, and physical examination 2. Blood sample collection and biochemical assessment At baseline and after the intervention, 10 ml of venous blood will be withdrawn from each participant. 3 ml of blood will be used for immediate determination of routine parameters including: * Hemoglobin concentration. * Ertherythrocyte sedimentation rate (ESR). * Prothrombin time. Two ml of blood will be immediately centrifuged at 3000 rpm for 10 min for immediate determination of: \- Serum albumin The remaining 5 ml of blood will be used for the analysis of the biological parameters which include: * Malondialdehyde (MDA) as oxidative stress marker (colorimetry). * Tumor necrosis factor-alpha (TNF-α) as pro inflammatory marker (ELISA). * Caspase-3 as a potential marker for apoptosis (ELISA). 3. Clinical assessment Clinical assessment will be done through determination of: A. Disease severity which will be assessed according to the modified Truelove and Witt's classification. B. The activity index (AI) for ulcerative colitis which is expressed as follows: AI = 60 x blood stool + 13 x bowel movements (frequency of defection) + 0.5 x ESR - 4 x Hb - 15 x albumin + 200. C. Health-related Quality of Life (HRQoL) using The Short Inflammatory Bowel Disease Questionnaire (SIBDQ). D. Assessement of pain score through the brief pain inventory short form "BPI-SF" worst item.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Placebo	placebo tablets twice daily
DRUG	Diosmin	diosmin 600 mg twice daily

Timeline

• Start date: 2022-12-15
• Primary completion: 2023-11-01
• Completion: 2024-11-01
• First posted: 2022-11-23
• Last updated: 2023-04-12

Locations

1 site across 1 country: Egypt