NIPH Clinical Trials Search

Effect of placenta supplement on chronic fatigue in the patient with moderately advanced liver cirrhosis

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	liver cirrhosis
Date of first enrollment	2019/03/24
Target sample size	10
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Placenta extract ( JBP porcine 100: 350mg a capsule), 6 capsules per day, 24 weeks

Outcome(s)

Primary Outcome

Estimation of general fatigue by questionnaire before, 12, 24 weeks after beginning administration of placenta extract and 12 weeks after end of administration

Secondary Outcome

Estimation of liver disease specialized QOL questionnaire, total bilirubin, total protein, serum albumin annmonia, ferritin, prothrombin time, AST, ALT, BUN, serum creatinine, free fatty acid, IRI, blood suger, Na, K, Cl, hyaluronic acid, type IV collagen 7s, M2BPGi, hepcidin, BMP receptor binging factor, check sheet for muscle cramp (visual analogue scale), total body water, total body muscle volume, total body fat volume estimated body composition analyzer and grip before, 12, 24 weeks after beginning administration of placenta extract and 12 weeks after end of administration

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	90years-old
Gender	Male and Female
Include criteria
Exclude criteria	1)patients hypersensitive to placenta 2)patients with uncontrolled hepatoma 3) complicated other malignancy and survival prognosis is one year or less 4) psychosomatic disorder or neurological disorder except for hepatic encephalopathy 5) severe infection example for tuberculosis