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
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
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
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
