Study of effects of Nobelzin capsules (zinc acetate) on hyperammonemia in patients with liver cirrhosis; A randomized, double-blind, placebo-controlled study in patients with liver cirrhosis

UMIN ID: UMIN000002402

Registered date:15/09/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Liver Cirrhosis
• Date of first enrollment: 2009/09/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patietns will receive 3 capsules of Nobelzin (zinc acetate, 1 capsule includes 50mg zinc) per day for 12 weeks
Patietns will receive 3 capsules of placebo per day for 12 weeks

Outcome(s)

• Primary Outcome: Serum levels of ammonia (0-week and 12-week) Adverse effects(during trial, 0-12 week)
• Secondary Outcome: Serum levels of BTR, psychometric testing, hepatic coma grade (0-week and 12-week)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Hepatic coma grade >= 3 2.Fulminant hepatitis 3.Patients with malignant diseases who need to be treated during the period of this trial 4.Patients with cardiac, renal or pancreatic diseases who need admission for the therapy 5.Patients who are associated with heavy hematological disorders or cerebrovascular diseases 6.Known or suspected history of allergy to zinc 7.Inegible patients at a physician's discretion

Related Information

• Primary Sponsor: Ministry of Health, Labour and Welfare
• Source(s) of Monetary Support: Research grant from the Japanese Ministry of Health, Labour and Welfare