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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018102
Receipt No. R000020950
Scientific Title Effect of plasmalogen-containing food on patients with Parkinson's disease or Parkinsonian syndromes -an open trial-
Date of disclosure of the study information 2015/06/26
Last modified on 2016/06/27

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Basic information
Public title Effect of plasmalogen-containing food on patients with Parkinson's disease or Parkinsonian syndromes -an open trial-
Acronym Effect of plasmalogen-containing food on patients with Parkinson's disease or Parkinsonian syndromes
Scientific Title Effect of plasmalogen-containing food on patients with Parkinson's disease or Parkinsonian syndromes -an open trial-
Scientific Title:Acronym Effect of plasmalogen-containing food on patients with Parkinson's disease or Parkinsonian syndromes
Region
Japan

Condition
Condition Parkinson's disease, Parkinsonian syndrome
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects on the improvement in symptoms and the plasmalogen hemodynamic alteration by 6-month administration of plasmalogen-containing food
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes UPDRS
Key secondary outcomes 1) H&Y
2) Schwab & England
3) PDQ-39

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 To administer the test food containing 0.5 mg of plasmalogen twice a day for 6 months and observe the changes of UPDRS and other medical indices
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Informed consents are obtained in writing from patients or one of their caretakers
2. Those who regularly go to hospitals conducting this study (regardless of gender)
3. Those who are judged as suitable for participation in this study by responsible doctors at the beginning of the study
Key exclusion criteria 1. Those who have scallop allergy
2. Those who are judged as not suitable for participation in this study by responsible doctors at the beginning of the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Ohara
Organization BOOCS clinic Fukuoka
Division name Functional neurology
Zip code
Address 6-18 Tenya-machi, Hakata-ku, Fukuoka city
TEL 092-283-6852
Email fukuoka@boocsclinic.com

Public contact
Name of contact person
1st name
Middle name
Last name Etsuko Kifuji
Organization BOOCS clinic Fukuoka
Division name director of nursing
Zip code
Address 6-18 Tenya-machi, Hakata-ku, Fukuoka city
TEL 092-283-6852
Homepage URL
Email kifuji@boocsclinic.com

Sponsor
Institute BOOCS clinic Fukuoka
Institute
Department

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

Other related organizations
Co-sponsor
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
2015 Year 06 Month 26 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 Completed
Date of protocol fixation
2015 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 26 Day
Last modified on
2016 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020950

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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