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

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: Diosmin

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sample collection and biochemical assessment At baseline and after the intervention, 10 ml of venous blood will be withdrawn from each participant.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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Tanta University Hospital
    • Contact: Tanta University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; Group I (Control group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo tablets twice daily for 3 months.	Drug: Placebo; placebo tablets twice daily
Experimental: diosmin group; Group II: (Diosmin group; n=30) which will receive mesalamine 1000 mg three times daily plus diosmin 600 mg twice daily for 3 months.	Drug: Diosmin; diosmin 600 mg twice daily; Other Names: diosimax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the change in Truelove and Witt's classification.	at baseline then after 3 months
the change in health related quality of life (HRQoL) questionnaire	at baseline then after 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
the change in the measured biological parameters (TNF alpha, MDA, caspase-3)	at baseline then after 3 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 36031/11/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No