the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis

NCT05626166 | Unknown Phase 3

• 1 other identifier: 36031/11/22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• the change in the measured biological parameters (TNF alpha, MDA, caspase-3)

  at baseline then after 3 months

Study Arms (2)

control group

PLACEBO COMPARATOR

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

diosmin group

EXPERIMENTAL

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

Interventions

Placebo DRUG

placebo tablets twice daily

control group

Diosmin DRUG

diosmin 600 mg twice daily

Also known as: diosimax

diosmin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university hospital

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Diosmin

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• tarek M mostafa, professor

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

amira B ismail, master

CONTACT

00201142760505; amira7794.aa@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This proof of concept study will be designed to be a randomized, double-blind, placebo controlled parallel study, The blindness will be maintained by the similarity in appearance, color and shape between placebo and diosmin tablets.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist

Model Details: 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. Patients will be recruited from Tropical Medicine Department, Tanta University Hospital, Tanta, Egypt. The patient will be followed for 3 months. The blindness will be maintained by the similarity in appearance, color and shape between placebo and diosmin tablets. The patients will be randomized in a 1:1 ratio by neutral researcher using sealed envelopes methods with assignment codes 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

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 23, 2022
• Study Start: December 15, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)