Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis

Tanta University

Status and phase: Completed; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Pentoxifylline 400 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05558761

3455 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Control Group

No Intervention group

Description:

this group will take mesalamine 1 g three times daily

Pentoxifylline group

Active Comparator group

Description:

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

Treatment:

Drug: Pentoxifylline 400 MG