UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035522
Receipt number R000040469
Scientific Title Effect of placenta supplement on chronic fatigue in the patient with moderately advanced liver cirrhosis
Date of disclosure of the study information 2019/01/11
Last modified on 2021/07/19 14:30:59

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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 or person

Institute

Shimane University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040469


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name