UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025559 |
|---|---|
| Receipt number | 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 10:09:52 |
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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
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
tatebe@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029416
