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Effect of angiotensin II receptor type 1 blocker and branched-chain amino acids on small intestinal pathological lesions in patients with liver cirrhosis

Effect of angiotensin II receptor type 1 blocker and branched-chain amino acids on small intestinal pathological lesions in patients with liver cirrhosis - Effect of ARB and BCAA on small intestine of cirrhotic patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012065
Enrollment
120
Registered
2013-10-21
Start date
2013-10-21
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Liver cirrhosis

Interventions

1) Angiotensin II receptor blocker 2) Branched-chain amino acids Use normal dose 1) Angiotensin II receptor blocker Use normal dose 1) Branched-chain amino acids Use normal dose No medicatio

Sponsors

The third department of internal medicine, Nara Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients over 20 years old 2) Patients obtained written informed consent 3) Life expectancy of at least 12 weeks 4) Patients with an ECOG Performance Status (PS) score of 0 or 1 5) Patinets with Child-Pugh class A, B cirrhosis 6) Adequate organ function a.Hb>= 8.0g/dL b.Neutrophil>=1500 /mm3 c.PLT>= 50000 /mm3 d.T-Bil< 3.0 mg/dL e.AST and ALT<= within 6 times of normal limit f.Cre<= within 1.5 times of normal limit

Exclusion criteria

Exclusion criteria: 1) Patients with malignant tumor 2) Patients with severe heart disease 3) Patients with severe and active infectious disease except viral hepatitis 4) Patients with HIV 5) Patients with severe renal dysfunction 6) Patienst with intracranial tumor 7) Patients with on going refractory hepatic coma 8) Patients with refractory ascites and pleural effusion 9) Patients with crutial digestive bleedings within 4 weeks 10) Ptients with intravascular thrombosis within 6 months except portal thrombosis 11) Patients with the following issues a. Systemic chemotherapy against HCC b. Partial hepatectomy or local treatment against HCC within 4 weeks c. Being treated with anticoagulant drugs d. Being treated with invasive surgical therapy within 4 weeks e. Having been treated with organ transplantation f. Being treated with bone marrow transplantation within 4 weeks 12) Patients with oral intake difficulty 13) Patients with severe digestive diseases 14) Patients taking a tablet which would affect this clinical study 15) Patients without normal absorbing function 16) Patients having been resistered in other clinical study within 4 weeks 17) Pregnant woman, lactating woman, or a woman suspected of pregnancy 18) Patients with severe allergic reaction 19) Patients with drug abuse or psycological disorders 20) Patients taking aliskiren hemifumarate 21) Patients concluded to be inappropriate to participate in this study by their physitians

Design outcomes

Primary

MeasureTime frame
Periods between the date of primary resistration and the date of newly occurred varices recognition in digestive organs

Secondary

MeasureTime frame
Periods between the date of primary resistration and the date of varices rupture (or very similar situation to rupture) in digestive organs

Countries

Japan

Contacts

Public ContactKEI MORIYA

Nara Medical University The third department of internal medicine

moriyak@naramed-u.ac.jp0744-22-3051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026