Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis
NCT ID: NCT05284448
Last Updated: 2024-06-21
Study Results
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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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2022-02-01
2022-10-01
Brief Summary
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Detailed Description
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Pentoxifylline (PTX) is a xanthine derivative drug with a wide range of actions at the cellular and molecular level. PTX possess anti-inflammatory, antioxidant activities. PTX have potential role in improvement of NASH . Also, PTX inhibits a number of pro-inflammatory cytokines including interleukin-1, interleukin-6 and tumor necrosis factor (TNF-α ) which play an important role in the pathogenesis and progression of NASH.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pentoxifylline Group
25 patients will receive pentoxifylline (Trental SR®) 400 mg three times daily with their standard therapy for 6 months.
pentoxifylline (Trental SR®)
400 mg three times daily
Control Group
25 patients will receive their standard therapy only
No interventions assigned to this group
Interventions
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pentoxifylline (Trental SR®)
400 mg three times daily
Eligibility Criteria
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Inclusion Criteria
2. Both sexes
3. Patients who have nonalcoholic steatohepatitis (NASH) will be diagnosed by
1. clinical examination (obese, high body mass index).
2. radiological criteria of fatty liver (abdominal ultrasonography).
3. laboratory investigation (elevated liver enzymes aspartate transaminase (AST), alanine transaminase (ALT).
4. The ability to give informed consent
5. Appropriate exclusion of other liver diseases
Exclusion Criteria
2\. Patients will be excluded if they had a history of past excessive alcohol drinking for a period longer than 2 years at any time in the past 10 years.
3\. Patients also will be excluded if they take medications known to cause steatosis or taking medications that have shown benefits in previous NASH pilot studies, including vitamin E, , thiazolidinedione, and alpha-glucosidase inhibitors.
4\. Patients with a history of hypersensitivity to PTX or the methylxanthines (caffeine, theophylline, and theobromine) will be excluded, as well as those with a history of cerebral
18 Years
65 Years
ALL
No
Sponsors
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Al-Azhar University
OTHER
Responsible Party
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ahmed salah saad abomandour
Principal Investigator
Principal Investigators
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Zeinab Zalat, PhD
Role: STUDY_CHAIR
Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy, Al-Azhar University(Girls, Cairo)
Adel Gaber Bakr, PhD
Role: STUDY_DIRECTOR
Assistant Professor of Pharmacology and Toxicology, Al-Azhar University (Boys, Assiut)
Ahmed ElGhandour, MD
Role: STUDY_DIRECTOR
Assistant Professor of Internal Medicine and Gastroenterology, Faculty of Medicine, Ain-Shams University
ahmed abomandour, Demonstrator
Role: PRINCIPAL_INVESTIGATOR
Demonstrator of Clinical Pharmacy Department, Faculty of Pharmacy, Al-Azhar University (Boys, Assiut)
Locations
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Internal medicine and hepatology outpatient clinic at Ain Shams University Hospital.
Cairo, , Egypt
Countries
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References
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Leoncini L, Vindigni C, Megha T, Funto I, Pacenti L, Musaro M, Renieri A, Seri M, Anagnostopoulos J, Tosi P. Epstein-Barr virus and gastric cancer: data and unanswered questions. Int J Cancer. 1993 Apr 1;53(6):898-901. doi: 10.1002/ijc.2910530605.
Girolami A. Tentative and updated classification of factor X variants. Acta Haematol. 1986;75(1):58-9. doi: 10.1159/000206084. No abstract available.
Other Identifiers
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312
Identifier Type: -
Identifier Source: org_study_id
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