The effect of Polypill on liver-related events in residents over 50 years in Gonbad city of Golestan province

Determining the effect of a combination pill of 81mg ASA, 20 mg atorvastatin, 12.5 mg hydrochlorothiazide, and 40mg valsartan on liver-related events in residents over 50 years in Gonbad city of Golestan province

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201111204092N3

Enrollment

1500

Registered

2012-02-25

Start date

2011-09-23

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 steatohepatitis. Nonalcoholic steatohepatitis (NASH)

Interventions

Intervention 1: Physical examination every 6 months. Intervention 2: Polypill (81 mg aspirin, 20 mg atorvastatin, 12.5 mg hydrochlorothiazide, 40 mg valsartan) daily for 5 years + physical exam every

Prevention

Physical examination every 6 months

Polypill (81 mg aspirin, 20 mg atorvastatin, 12.5 mg hydrochlorothiazide, 40 mg valsartan) daily for 5 years + physical exam every 6 months

Eligibility

Sex/Gender

All

Age

50 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Subjects above 50 enrolled in the Golestan Cohort Study. Exclusion criteria: Contraindication to any component of the polypill; active or severe liver disease; severe medical conditions; not consenting to the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Changes in liver enzymes (AST and ALT). Timepoint: After 6 months and then once a year. Method of measurement: Elisa.;Changes in ultrasonographic findings. Timepoint: Year 0, 2, 5. Method of measurement: Ultrasonography.;Changes in liver stiffness. Timepoint: Year 0, 2, 5. Method of measurement: FibroScan.;Cardiovascular events. Timepoint: every 6 months. Method of measurement: Direct questioning.	—

Measure

Time frame

Changes in liver enzymes (AST and ALT). Timepoint: After 6 months and then once a year. Method of measurement: Elisa.;Changes in ultrasonographic findings. Timepoint: Year 0, 2, 5. Method of measurement: Ultrasonography.;Changes in liver stiffness. Timepoint: Year 0, 2, 5. Method of measurement: FibroScan.;Cardiovascular events. Timepoint: every 6 months. Method of measurement: Direct questioning.

—

Secondary

Measure	Time frame
Compliance. Timepoint: every 6 months. Method of measurement: Questioning.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahin Merat

Tehran University of Medical Sciences

merat@tums.ac.ir+98 21 8241 5104

Outcome results

None listed

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