Effect of placenta supplement on chronic fatigue in the patient with moderately advanced liver cirrhosis
Phase 1
- Conditions
- iver cirrhosis
- Registration Number
- JPRN-jRCTs061180092
- Lead Sponsor
- Tobita Hiroshi
- Brief Summary
Administration of the placenta supplement to patients with cirrhosis did not significantly improve the FIS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
1) Patients over the age of twenty with Child grade B liver cirrhosis
2) Consent is obtained in writing
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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