Skip to content

A multicenter randomized controlled clinical trial of the superiority of compound polyethylene glycol 3350 (PEG) oral solution in the treatment of overt hepatic encephalopathy

A multicenter randomized controlled clinical trial of the superiority of compound polyethylene glycol 3350 (PEG) oral solution in the treatment of overt hepatic encephalopathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105829
Enrollment
Unknown
Registered
2025-07-11
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

hepatic encephalopathy (HE)

Interventions

Standard control group:Lactulose, swallow, starting dose 30ml, three times a day, adjusted to a maximum of 2-3 soft stools per day.
Study TREATMENT GROUPS:PEG, Swallow, starting dose 25ml, 3 times a day, adjusted to a maximum of 2-3 soft stools per day.

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-65 years; 2. In line with the diagnosis of hepatic encephalopathy type C in the guidelines for the diagnosis and treatment of hepatic encephalopathy in cirrhosis (2024 edition); 3. Grade 1-3 HE (using HESA grading standard); 4. meet one of the conditions for increased intestinal NH3 production; 5. Informed consent from guardians.

Exclusion criteria

Exclusion criteria: 1. liver failure (TB>=170umol/L+PTA<=40%); 2. previous Tips or other portosystemic shunt; 3. The neuropsychiatric symptoms were not caused by HE; 4. Use of lactulose or compound polyethylene glycol 3350 oral solution after the onset of the disease; 5. HESA4 (at the same time: unable to open eyes voluntarily, unable to respond to calls, unable to complete simple commands); 6. lack of informed consent; 7. Refusal of informed consent; 8. having participated in this study; 9. Pregnant women and other special people.

Design outcomes

Primary

MeasureTime frame
An improvement of 1 grade or more in HESA score after 24 hours of treatment was considered effective;

Secondary

MeasureTime frame
Complete remission of HESA score;

Countries

China

Contacts

Public ContactLi Lufeng

The First Affiliated Hospital of Army Medical University

609172623@qq.com+86 13896575833

Outcome results

None listed

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