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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025559
Receipt No. R000029416
Scientific Title Examination of the acupuncture for the neurologic disease with muscle tone abnormalities including the Parkinson's syndrome.
Date of disclosure of the study information 2017/01/06
Last modified on 2018/01/09

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Basic information
Public title Examination of the acupuncture for the neurologic disease with muscle tone abnormalities including the Parkinson's syndrome.
Acronym Effects of acupuncture in Parkinsonism.
Scientific Title Examination of the acupuncture for the neurologic disease with muscle tone abnormalities including the Parkinson's syndrome.
Scientific Title:Acronym Effects of acupuncture in Parkinsonism.
Region
Japan

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

Objectives
Narrative objectives1 We examine an effect and safety of the acupuncture on Parkinson's syndrome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PDQ-8
Key secondary outcomes UPDRS (Unified Parkinson's Disease Rating Scale)
The incidence of side effect

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Acupuncture treatment
Interventions/Control_2 Normal treatment
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) Ambulant patient
2) No acupuncture treatment in the last three months.
3) Subjects who gave the written informed consent.
Key exclusion criteria 1) The change of medications in this study.
2) Pregnant or lactating women
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiki Mizuno
Organization Kyoto Prefectural University of Medicine
Division name Department of Neurology
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-0841, Japan
TEL 075-251-5793
Email mizuno@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Harutsugu Tatebe
Organization Kyoto Prefectural University of Medicine
Division name Department of Homecare(Zaitaku) Medicine
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-0841, Japan
TEL 075-251-5875
Homepage URL
Email tatebe@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Other
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
2017 Year 01 Month 06 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
2015 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 06 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
2017 Year 01 Month 06 Day
Last modified on
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029416

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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