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Comparative Effectiveness and Safety of Polyethylene Glycol Versus Lactulose for Treatment of Hepatic Encephalopathy

Comparative Effectiveness and Safety of Polyethylene Glycol Versus Lactulose for Treatment of Hepatic Encephalopathy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250903067114N1
Enrollment
50
Registered
2025-10-20
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Hepatic Encephalopathy. Hepatic failure,not elsewhere classified

Interventions

Intervention 1: Intervention Group :1 – Lactulose: Oral lactulose, 45–90 mL three times daily for 14 days. Intervention 2: Intervention group: 2 – Polyethylene Glycol (PEG): Oral PEG, 30–60 g three ti

Sponsors

Boushehr University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 years or older Diagnosis of liver cirrhosis based on clinical, laboratory, and imaging criteria Hepatic encephalopathy grade I to IV according to the West-Haven criteria

Exclusion criteria

Exclusion criteria: Lack of consent to participate in the study History of allergy to lactulose or PEG Presence of other liver diseases such as acute viral hepatitis or primary biliary cholangitis Severe liver failure (Child-Pugh C) Active gastrointestinal bleeding

Design outcomes

Primary

MeasureTime frame
Hepatic encephalopathy severity using HESA. Timepoint: Daily (14 days). Method of measurement: Daily assessment by physician or nurse.;In-hospital mortality/Alive or deceased status during hospitalization. Timepoint: Until discharge. Method of measurement: record from patient medical record.

Secondary

MeasureTime frame
In hospital mortality. Timepoint: At the end of hospitalization. Method of measurement: In-hospital mortality is recorded in the patient’s medical record by the attending physician, including the date and cause of death.;Length of hospital stay (day). Timepoint: At discharge or death. Method of measurement: Outcome Measurement Method: Calculated as the difference between discharge and admission dates and recorded in the patient’s medical record.;Lenght of ICU stay (days). Timepoint: At discharge or death. Method of measurement: Calculated from ICU admission and discharge dates and recorded in the patient’s medical record.;Requirment for ICU admission (yes/no). Timepoint: Assessed at any time during hospitalization. Method of measurement: Recorded in the patients medical record if transferred to ICU.;Drug related adverse events(type and severity). Timepoint: Monitored daily during hospitalization. Method of measurement: Monitored daily by the medical team and recorded with type and severity in the patients medical record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBijan Vaziri

Boushehr University of Medical Sciences

Bijanvaziri7223@gmail.com+98 77 3345 5374

Outcome results

None listed

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