Irsogladine maleate and its exerted clinical effects on portal hypertensive gastropathy associated with cirrhosis: A double-blind randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250311002

Enrollment

Registered

2025-03-11

Start date

2023-12-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Reduction of portal hypertensive gastropathy after 12-week treatment of irsogladin portal hypertensive gastropathy

Interventions

Isogladine 4 mg once daily was administered for a 12-week duration.,Placebo was administered for a 12-week duration.

Active Comparator Drug,Placebo Comparator Drug

lsogladine,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Subjects who were endoscopically diagnosed with PHG by gastroenterologists within the previous 1 month.

Exclusion criteria

Exclusion criteria: 1. Subjects have undergone recent endoscopic variceal ligation or sclerotherapy within 6 months. 2. Subjects had non-cirrhotic portal hypertension etiology. 3. Subjects treated for liver cancer. 4. Subjects have undergone major surgical procedure including TIPS, transcatheter splenic arterial embolization, surgical shunt, laparoscopic splenectomy, liver transplantation.

Design outcomes

Primary

Measure	Time frame
Endoscopic portal hypertensive gastropathy(PHG) severity score improvement at 12-week Endoscopic PHG severity score	—

Secondary

Measure	Time frame
Gastrointestinal symptom At 12-week a questionnaire interview	—

Countries

Thailand

Contacts

Public ContactChanunta HONGTHANAKORN

Bhumibol Adueyadej Hospital

rabbithap@yahoo.com0824591966

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026