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NCT05558761 | Recruiting | Inflammatory Bowel Diseases


Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis
Sponsor:

Lots of University

Information provided by (Responsible Party):

Mostafa is very

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.

Condition or disease

Inflammatory Bowel Diseases

Intervention/treatment

Pentoxifylline 400 MG

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 50 participants
Masking : Double
Masking Description : double-blinded
Primary Purpose : Treatment
Official Title : Clinical Study to Evaluate the Possible Efficacy of Pentoxifylline in Patients With Ulcerative Colitis Treated With Mesalamine
Actual Study Start Date : October 10, 2022
Estimated Primary Completion Date : October 20, 2024
Estimated Study Completion Date : February 20, 2025
Arm Intervention/treatment

No Intervention: Control Group

this group will take mesalamine 1 g three times daily

Active Comparator: Pentoxifylline group

his group will take mesalamine 1 g three times daily plus pentoxifylline 400 mg two times daily

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis

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Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis

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Locations


Recruiting

Egypt,

Faculty of Medicine, Mansoura University

Mansoura, Egypt, 35511

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