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The aim of the present study is to evaluate the efficacy and safety of pentoxifylline in the treatment of non-alcoholic steatohepatitis patients.
Nonalcoholic steatohepatitis(NASH) is the progressive form of Non-alcoholic fatty liver disease (NAFLD), is characterized by hepatocellular damage, inflammation, and liver fibrosis that can progress to cirrhosis, in 25% of patients, NAFLD progresses to NASH, which increases the risk for the development of cirrhosis, liver failure, and hepatocellular carcinoma. In patients with NASH, liver fibrosis is the main determinant of mortality.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxifylline Group | Experimental | 25 patients will receive pentoxifylline (Trental SR®) 400 mg three times daily with their standard therapy for 6 months. |
|
| Control Group | No Intervention | 25 patients will receive their standard therapy only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pentoxifylline (Trental SR®) | Drug | 400 mg three times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| improvement in liver aminotransferases(ALT and AST) | Difference between last and first measurements | 6 months compared to the baseline |
| NAFLD fibrosis score (NFS) | Change in NAFLD fibrosis score (NFS) (lower score means better outcome). | 6 months compared to the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| The Aspartate (AST) to Platelet Ratio Index (APRI) score: | Change in (APRI) score (lower score means better outcome). | 6 months compared to the baseline |
| The Fibrosis-4 (FIB-4) values: | Change in (FIB-4) values (lower values means better outcome). |
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Inclusion Criteria:
Aged between 18- 60 years old.
Both sexes
Patients who have nonalcoholic steatohepatitis (NASH) will be diagnosed by
The ability to give informed consent
Appropriate exclusion of other liver diseases
Exclusion Criteria:
1- Patients with other diagnosed chronic liver diseases as viral hepatitis, metabolic and genetic disorders as Hemochromatosis, Wilson disease, autoimmune hepatitis and drug induced liver disease as well as patients with recent infection and those who refused to be entitled in the study.
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
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| Name | Affiliation | Role |
|---|---|---|
| Zeinab Zalat, PhD | Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy, Al-Azhar University(Girls, Cairo) | Study Chair |
| Adel Gaber Bakr, PhD | Assistant Professor of Pharmacology and Toxicology, Al-Azhar University (Boys, Assiut) | Study Director |
| Ahmed ElGhandour, MD | Assistant Professor of Internal Medicine and Gastroenterology, Faculty of Medicine, Ain-Shams University | Study Director |
| ahmed abomandour, Demonstrator | Demonstrator of Clinical Pharmacy Department, Faculty of Pharmacy, Al-Azhar University (Boys, Assiut) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internal medicine and hepatology outpatient clinic at Ain Shams University Hospital. | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7682538 | Background | 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. | |
| 3088890 | Background | Girolami A. Tentative and updated classification of factor X variants. Acta Haematol. 1986;75(1):58-9. doi: 10.1159/000206084. No abstract available. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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Clinical trial, parallel, randomized, prospective, controlled study
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| 6 months compared to the baseline |
| Serum Alkaline Phosphatase level (ALP) | Change in ALP serum level as inflammatory markers of NASH | 6 months compared to the baseline |
| Serum Gamma-glutamyl Transferase level (GGT) | Change in GGT serum level as inflammatory markers of NASH | 6 months compared to the baseline |
| Serum total and direct bilirubin. | Change in levels of serum total and direct bilirubin. | 6 months compared to the baseline |
| Waist circumference | Change in waist circumference | 6 months compared to the baseline |
| Change in anthropometric measures | including BMI etc. | 6 months compared to the baseline |
| Lipid profile | Change in serum lipids | 6 months compared to the baseline |
| Glycated hemoglobin (HbA1C) | Change in HbA1C level for patients with T2DM | 6 months compared to the baseline |
| Fasting blood glucose level | Change in fasting blood glucose for patients with T2DM | 6 months compared to the baseline |
| Drugs adverse events | Assessment of safety by reporting any adverse events | 6 months compared to the baseline |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |