Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-03-01

Brief Summary

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Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.

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Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control Group

this group will take mesalamine 1 gm three times daily for 6 months

Group Type NO_INTERVENTION

No interventions assigned to this group

metformin group

this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily

Interventions

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Metformin

metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Both males and females will be included
* Negative pregnancy test and effective contraception

Exclusion Criteria

* •

* Breast feeding
* Significant liver and kidney function abnormalities
* Diabetic patients
* Colorectal cancer patients
* Patients with severe UC
* Patients taking rectal or systemic steroids
* Patients taking immunosuppressives or biological therapies
* Addiction to alcohol and / or drugs
* Known allergy to the studied medications

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No