Skip to content

Evaluation of allopurinol efficacy in patients with nonalcoholic fatty liver disease

Evaluation of allopurinol efficacy in patients with nonalcoholic fatty liver disease: a randomized, double blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160920029889N1
Enrollment
44
Registered
2018-01-09
Start date
2018-01-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nonalcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: reception of allopurinol 300 mg (manufacturing Ramopharmin Pharmaceutical Company) once a day, for 4 months. Intervention 2: Control group: reception of placebo (ma
Treatment - Drugs
Placebo
Intervention group: reception of allopurinol 300 mg (manufacturing Ramopharmin Pharmaceutical Company) once a day, for 4 months
Control group: reception of placebo (manufacturing faculty of pharmacy) once a day, for 4 months

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 70 years Not having history of alcohol consumption Lack of other liver diseases The levels of aminotransferases should not exceed 2.5 times the upper limit of normal No previous allergy to allopurinol Not having chronic kidney disease (definedas an estimated glomerular filtration rate <60 mL/min/1.73m2) Serum uric acid levels greater than 4 mg/dl for men and more than 3 mg/dl for women For diabetic patients, hemoglobin A1c should be less than 8% and the dose of antidiabetic drugs should be constant for at least 3 months Not having hematological disorders Not having kidney stones

Exclusion criteria

Exclusion criteria: Pregnancy and lactation Use of drugs interact with allopurinol (including didanosine, angiotensin-converting enzyme inhibitors, antacids (except sodium bicarbonate), azathioprine, mercaptopurine, vitamin K antagonists (including warfarin and other coumarin derivatives)) Taking hepatotoxic drugs (including calcium channel blockers, high doses of synthetic estrogens, methotrexate, amiodarone, chloroquine) Occurrence of allergic reaction due to allopurinol intake

Design outcomes

Primary

MeasureTime frame
Change in liver steatosis. Timepoint: before the intervention and at the end of the study. Method of measurement: abdominal computed tomography scans-no contrast injection-spiral (liver hounsfield unit and the liver attenuation index (liver hounsfield unit minus spleen hounsfield unit)).;Change in systemic inflammation. Timepoint: before the intervention and at the end of the study. Method of measurement: high sensitivity c-reactive protein.

Secondary

MeasureTime frame
Change in insulin resistance. Timepoint: before the intervention and at the end of the study. Method of measurement: homeostasis model assessment of insulin resistance.;Change in oxidative stress. Timepoint: before the intervention and at the end of the study. Method of measurement: malondialdehyde.;Change in lipid profile. Timepoint: before the intervention and at the end of the study. Method of measurement: triglycerides, total cholesterol, high density lipoprotein, low density lipoprotein.;Change in liver enzymes. Timepoint: before the intervention and at the end of the study. Method of measurement: alanine aminotransferase, aspartate aminotransferase.;Change in anthropometric measurements. Timepoint: before the intervention and at the end of the study. Method of measurement: weight, body mass index, waist circumference, hip circumference, waist to hip ratio.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfshin Shiva

Oroumia University of Medical Sciences

shiva@umsu.ac.ir+98 44 3275 4991

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026