Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis

Phase 2

Recruiting

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Pentoxifylline 400 MG

• Registration Number: NCT05558761
• Lead Sponsor: Tanta University

Brief Summary

The exact underlying mechanisms of ulcerative colitis (UC), an idiopathic, chronic inflammatory disease marked by diffused inflammation of the colon and rectum mucosa, are still unknown. Due to genetic, immune, and environmental factors, UC is highly dependent on cellular immune reactions and exaggerated inflammatory responses. The release of several cytokines, kinins, leukotrienes, platelet-activating factor (PAF), and reactive oxygen species is connected to immunological activity (ROS). Additionally, many of the cytokines will start an acute phase response, making the inflammation worse.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-09-25
• Study First Posted: 2022-09-28
• Study Start: 2022-10-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-27
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-10-20
• Study Completion: 2025-02-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

• Breastfeeding Significant liver and kidney function abnormalities Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids Known allergy to the studied medications

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pentoxifylline group	Pentoxifylline 400 MG	his group will take mesalamine 1 g three times daily plus pentoxifylline 400 mg two times daily

Primary Outcome Measures

Name	Time	Method
Improvement in health related quality of life	6 months	Short Form 36 Health Survey (SF-36) will assess the quality of life. The SF-36 is an indicator of overall health status and contains 10 items. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability

Secondary Outcome Measures

Name	Time	Method
changes in the level of measured biomarkers.	6 months	changes in the level of measured biomarkers through assessment serum level of TNF- alpha, serum IL-10, and gene expression of zonula occuldin-1(ZO-1).

Trial Locations

Locations (1)

Faculty of Medicine, Mansoura University; 🇪🇬 Mansoura, Egypt