Efficacy of Deglusterol in fatty live disease

Efficacy of Deglusterol plus standard care in comparison with placebo and standard care in metabolic syndrome patients with non-alcoholic steatohepatitis: a randomized, double blind controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130707013886N3

Enrollment

150

Registered

2023-10-04

Start date

2023-09-21

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Non-alcoholic steatohepatitis. Nonalcoholic steatohepatitis (NASH)

Interventions

Intervention 1: Intervention group: deglusterol 1 sachet daily for 12 weeks + standard care. Intervention 2: Control group: include placebo 1 sachet daily for 12 weeks + standard care.

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Metabolic syndrom according to ATP III criteria At least grade 1 steatohepatitis in ultrasound exam

Exclusion criteria

Exclusion criteria: Alcoholic fatty liver disease

Design outcomes

Primary

Measure	Time frame
Steatohepatitis grade in abdominal sonography. Timepoint: 4 and 12 weeks. Method of measurement: Abdominal sonography.	—

Secondary

Measure	Time frame
Fasting Blood Glucose. Timepoint: Before intervention, weeks: 4 and 12. Method of measurement: Blood sample.;Weight, BMI. Timepoint: before intervention, 4 and 12 weeks. Method of measurement: weight and height scale.;HbA1c. Timepoint: before intervention, 4 and 12 weeks. Method of measurement: Blood sample.;Liver function tests. Timepoint: before intervention, 4 and 12 weeks. Method of measurement: Blood sample.;Lipid profile. Timepoint: before intervention, 4 and 12 weeks. Method of measurement: Blood sample.	—

Measure

Time frame

Fasting Blood Glucose. Timepoint: Before intervention, weeks: 4 and 12. Method of measurement: Blood sample.;Weight, BMI. Timepoint: before intervention, 4 and 12 weeks. Method of measurement: weight and height scale.;HbA1c. Timepoint: before intervention, 4 and 12 weeks. Method of measurement: Blood sample.;Liver function tests. Timepoint: before intervention, 4 and 12 weeks. Method of measurement: Blood sample.;Lipid profile. Timepoint: before intervention, 4 and 12 weeks. Method of measurement: Blood sample.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Vasheghani Farahani

Tehran University of Medical Sciences

avasheghani@tums.ac.ir009888029600

Outcome results

None listed

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