Clinical Study to Evaluate the Possible Efficacy of Pentoxifylline in Patients With Ulcerative Colitis Treated With Mesalamine
Overview
- Phase
- Phase 2
- Intervention
- Pentoxifylline 400 MG
- Conditions
- Inflammatory Bowel Diseases
- Sponsor
- Tanta University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Improvement in health related quality of life
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Mostafa Bahaa
Teaching Assistant
Tanta University
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception
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
Arms & Interventions
Pentoxifylline group
his group will take mesalamine 1 g three times daily plus pentoxifylline 400 mg two times daily
Intervention: Pentoxifylline 400 MG
Outcomes
Primary Outcomes
Improvement in health related quality of life
Time Frame: 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 Outcomes
- changes in the level of measured biomarkers.(6 months)