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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013386
Receipt No. 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

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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
Email 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
Email kura@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015619

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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