UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013386 |
|---|---|
| Receipt number | R000015619 |
| Scientific Title | The efficacy of L-Cartin for chronic fatigue syndrome |
| Date of disclosure of the study information | 2014/03/20 |
| Last modified on | 2017/09/11 17:25:18 |
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Basic information
Public title
The efficacy of L-Cartin for chronic fatigue syndrome
Acronym
The efficacy of L-Cartin for chronic fatigue syndrome
Scientific Title
The efficacy of L-Cartin for chronic fatigue syndrome
Scientific Title:Acronym
The efficacy of L-Cartin for chronic fatigue syndrome
Region
| Japan |
Condition
Condition
Chronic fatigue syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate an efficacy of taking "L-Cartin" which indicates for carnitine deficiency, for symptoms of chronic fatigue syndrome patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chalder Fatigue Scale,Performance
Status, Fatigue sensation : Visual Analog Scale
Key secondary outcomes
CES-D, POMS, Autonomic nervous system, Carnitine, Ammonia, arithmetic task, d-ROMs, BAP, sleep-wake cycle, near infrared spectrometer
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
L-Cartine FF 10 % (Otsuka Pharmacy, Co.LTD., Japan), 2000 mg / day, 8 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic fatigue syndrome (CFS) patients who visit Osaka City University Hospitals, Fatigue Clinical Center and are eligible for the following criteria.
(1) Patients fulfilling the CFS criteria determined by CDC (1994)
(2) Patients whose diseases duration are more than 6 months and less than 15 years
(3) Patients whose fatigue related performances status are equal or less than 3
(4) Patients who are less than 60 year-old and non-smokers at the time of getting the informed consent
(5) Patients whose body mass index are equal or more than 16 and equal and less than 30 at the time of getting the informed consent
(6) Patients who are capable of understanding the study, and those who can give written informed consents
Key exclusion criteria
(1)Patients comorbid with organic diseases which apparently induce fatigue except CFS
(2)During the pregnancy or nursing, or patients to be pregnant during the study period
(3)Patients who receive warfarin
(4)Patients who receive carnitine
(5)Others
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Inaba |
Organization
Osaka City University, Graduate School of Medicine
Division name
Metabolism, Endocrinology and Molecular Medicine
Zip code
Address
1-5-7, Asahi-machi, Abenoku, Osaka Cit
TEL
06-6645-2311
m1356849@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohiko Kuratsune |
Organization
Osaka City University, Graduate School of Medicine
Division name
Physiology
Zip code
Address
1-4-3, Asahi-machi, Abenoku, Osaka City
TEL
06-6646-3033
Homepage URL
kura@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
outside various funds
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamaguchi University, Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 03 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 08 | Month | 10 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 10 | Day |
Last modified on
| 2017 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015619
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
