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Formulation and clinical study of oral astaxanthin capsules as hepatoprotective in nonalcoholic fatty liver disease

Formulation and clinical study of oral astaxanthin capsules as hepatoprotective in nonalcoholic fatty liver disease

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250820066928N1
Enrollment
60
Registered
2025-08-31
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Non-alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention group: Intervention group: In the intervention group, in addition to lifestyle education, 12 mg astaxanthin capsules were given orally twice daily, 1 capsule each time, for 8 weeks..

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 80 Years

Inclusion criteria

Inclusion criteria: Major conditions for inclusion in the study before randomization: - Ultrasound report of fatty liver grade 1 and 2, increased ALT enzyme >40, increased AST enzyme <38, age between 12 and 80 years. Major conditions for not including in the study before randomization: Patient's unwillingness to participate in the pregnancy and breastfeeding plan, use of anticoagulant drugs, thyroid diseases, spleen disease, cirrhosis, viral hepatitis, or obstructive liver diseases, dyslipidemias under treatment, - Overt diabetes, pulmonary diseases, use of any medication that affects liver metabolism and enzymes, including oral contraceptives, corticosteroids, salazines.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Comparing the effect of astaxanthin capsules on the liver enzyme ALT (alanine transaminase) with placebo in patients with non-alcoholic fatty liver disease. Timepoint: at baseline( before the start of the intervention) and after 8 weeks of treatment. Method of measurement: Using a liver enzyme kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa SAbernavaei

Iran University of Medical Sciences

mahsa.navaei@gmail.com+98 21 4460 6181

Outcome results

None listed

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