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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000035054
Receipt No. R000039859
Scientific Title Safety and efficacy of scallop-derived plasmalogen on patients with chronic fatigue syndrome: an open-label study
Date of disclosure of the study information 2018/11/28
Last modified on 2019/04/19

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Basic information
Public title Safety and efficacy of scallop-derived plasmalogen on patients with chronic fatigue syndrome: an open-label study
Acronym Safety and efficacy of scallop-derived plasmalogen on patients with chronic fatigue syndrome: an open-label study
Scientific Title Safety and efficacy of scallop-derived plasmalogen on patients with chronic fatigue syndrome: an open-label study
Scientific Title:Acronym Safety and efficacy of scallop-derived plasmalogen on patients with chronic fatigue syndrome: an open-label study
Region
Japan

Condition
Condition Chronic fatigue syndrome
Classification by specialty
Medicine in general Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the improvement of symptoms by 12-week administration of scallop-derived plasmalogen
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes CFS questionnaire (baseline, 4W, 8W, 12W)
Key secondary outcomes Plasmalogen levels of blood plasma and erythrocyte membrane
Body temperature on awakening
State-Trait Anxiety Inventory(form X)
OSA Sleep Inventory
Athens Insomnia Scale(MA)

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 Treatment
Type of intervention
Food
Interventions/Control_1 Administration of the test food (0.5mg scallop-derived plasmalogen) twice per day for 12 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
70 years-old >
Gender Male and Female
Key inclusion criteria ・Written consent obtained for the participation in this study
・Subjects aged 20 to 70
・Subjects diagnosed as chronic fatigue syndrome
Key exclusion criteria ・Subjects having ever taken scallop-derived plasmalogen
・Subjects who are pregnant or lactating
・Subjects judged ineligible for this study by the investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeo Madarame
Organization Aoyama Madarame Clinic
Division name Director
Zip code
Address 6F 2-26-35 Aoyama, Minato-ku, Tokyo
TEL 03-3405-4976
Email madarame@dr-madarame.com

Public contact
Name of contact person
1st name
Middle name
Last name Chikako Wakana
Organization The Japanese Plasmalogen Society
Division name General Manager
Zip code
Address 6F 2-2, Tsunabamachi, Hakata-ku, Fukuoka
TEL 092-273-2411
Homepage URL
Email info@pls.jp

Sponsor
Institute Aoyama Madarame Clinic
Institute
Department

Funding Source
Organization The Japanese Plasmalogen Society
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Institute of Rheological Functions of Food
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 青山・まだらめクリニック 自律神経免疫治療研究所

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 28 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
2018 Year 11 Month 15 Day
Date of IRB
2018 Year 11 Month 15 Day
Anticipated trial start date
2018 Year 12 Month 03 Day
Last follow-up date
2019 Year 04 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 28 Day
Last modified on
2019 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039859

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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