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the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Placebo
Diosmin
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Tanta university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control group

diosmin group

Arm Description

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.

Outcomes

Primary Outcome Measures

the change in Truelove and Witt's classification.
the change in health related quality of life (HRQoL) questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2022
Last Updated
April 10, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05626166
Brief Title
the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis
Official Title
Clinical Study Evaluating the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis Treated With Mesalamine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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: Demography, history, and physical examination 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Group I (Control group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo tablets twice daily for 3 months.
Arm Title
diosmin group
Arm Type
Experimental
Arm Description
Group II: (Diosmin group; n=30) which will receive mesalamine 1000 mg three times daily plus diosmin 600 mg twice daily for 3 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo tablets twice daily
Intervention Type
Drug
Intervention Name(s)
Diosmin
Other Intervention Name(s)
diosimax
Intervention Description
diosmin 600 mg twice daily
Primary Outcome Measure Information:
Title
the change in Truelove and Witt's classification.
Time Frame
at baseline then after 3 months
Title
the change in health related quality of life (HRQoL) questionnaire
Time Frame
at baseline then after 3 months
Secondary Outcome Measure Information:
Title
the change in the measured biological parameters (TNF alpha, MDA, caspase-3)
Time Frame
at baseline then after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amira B ismail, master
Phone
00201142760505
Email
amira7794.aa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tarek M mostafa, professor
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta university hospital
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanta University Hospitals

12. IPD Sharing Statement

Plan to Share IPD
No

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the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis

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