UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of L-Cartin for chronic fatigue syndrome
Title of the study (Brief title)	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	Masaaki Inaba
Organization	Osaka City University, Graduate School of Medicine
Division name	Metabolism, Endocrinology and Molecular Medicine
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	Hirohiko Kuratsune
Organization	Osaka City University, Graduate School of Medicine
Division name	Physiology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 01 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015619