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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035522
Receipt No. 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 2019/01/11

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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
Middle name
Last name Tobita, Hiroshi
Organization Shimane University Hospital
Division name Hepatology
Zip code
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
Middle name
Last name Tobita, Hiroshi
Organization Shimane University Hospital
Division name Hepatology
Zip code
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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2019 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 24 Day
Last follow-up date
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
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.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


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