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NCT05616442CompletedPhase 4

Ketotifen in Non-Alcoholic Fatty Liver Disease Patients

Source: ClinicalTrials.gov · Last updated 6 Feb 2026

Brief summary (registry, in English)

The aim of this study is to investigate the safety and efficacy of using ketotifen in patients with NAFLD patients without cirrhosis

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
60 (actual)
First submitted
7 Nov 2022
Start date
20 May 2023
Primary completion date
1 Mar 2025
Lead sponsor
Tanta University
NCT number
NCT05616442

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 60
  • From 20 May 2023 to the primary completion date, 1 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • -Inclusion criteria: Adult males or females aged ≥18 years.
  • All patients are diagnosed to have fatty liver grading 1, 2 or 3 on abdominal ultrasound with Hepatic steatosis index \> 36 to be considered as a NAFLD patient.
  • Confirmed diagnosis of NASH
  • Exclusion Criteria:
  • Current or history of significant alcohol consumption.
  • Use of drugs historically associated with nonalcoholic fatty liver disease (NAFLD) (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins).
  • Prior or planned bariatric surgery.
  • Uncontrolled diabetes defined as Hemoglobin A1c 9.5% or higher.
  • Evidence of other forms of chronic liver disease as Hepatitis B, Hepatitis C, Wilson's disease, Alpha-1-antitrypsin (A1AT) deficiency, Hemochromatosis, drug-induced liver disease.
  • Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial and breast feeding.
  • Use of other drugs known to have possible positive effects on steatosis.
  • Other anti-histaminic, sedating agents (CNS depressants) and anticholinergic medications.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tanta Unuversity
Coordinator of this site? Confirm its status
TantaEgyptUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.