UMIN-CTR Clinical Trial

Basic information
Public title	Effect of placenta supplement on chronic fatigue in the patient with moderately advanced liver cirrhosis
Acronym	Effect of placenta supplement on chronic fatigue in the patient with moderately advanced liver cirrhosis
Scientific Title	Effect of placenta supplement on chronic fatigue in the patient with moderately advanced liver cirrhosis
Scientific Title:Acronym	Effect of placenta supplement on chronic fatigue in the patient with moderately advanced liver cirrhosis
Region	Japan

Condition
Condition	liver cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect to the fatigue of the placenta supplement on cirrhosis patient
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Estimation of general fatigue by questionnaire before, 12, 24 weeks after beginning administration of placenta extract and 12 weeks after end of administration
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Placenta extract ( JBP porcine 100: 350mg a capsule), 6 capsules per day, 24 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients over the age of twenty with Child grade B liver cirrhosis 2) Consent is obtained in writing
Key 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
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Tobita
Organization	Shimane University Hospital
Division name	Hepatology
Zip code	693-8501
Address	89-1, Enya-cho, Izumo-shi, Shimane
TEL	0853-20-2190
Email	ht1020@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Tobita
Organization	Shimane University Hospital
Division name	Hepatology
Zip code	693-8501
Address	89-1, Enya-cho, Izumo-shi, Shimane
TEL	0853-20-2190
Homepage URL
Email	ht1020@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Hospital
Institute
Department

Funding Source
Organization	Shimane University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shimane University Hospital
Address	Enya-cho, 89-1
Tel	0853202190
Email	kenkyu@med.shimane-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2019 Year 01 Month 10 Day
Date of IRB	2017 Year 04 Month 24 Day
Anticipated trial start date	2019 Year 03 Month 24 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 11 Day
Last modified on	2021 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040469