UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023856 |
|---|---|
| Receipt number | R000027486 |
| Scientific Title | Effects of acupuncture treatment on stress in patients with Parkinson's disease. |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2016/08/31 11:50:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of acupuncture treatment on stress in patients with Parkinson's disease.
Acronym
Effects of acupuncture treatment in patients with Parkinson's disease.
Scientific Title
Effects of acupuncture treatment on stress in patients with Parkinson's disease.
Scientific Title:Acronym
Effects of acupuncture treatment in patients with Parkinson's disease.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the effects of acupuncture efficacy on Parkinson's Disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
UPDRS (Unified Parkinson's Disease Rating Scale)
Key secondary outcomes
salivary cortisol, chromogranin A
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
acupuncture treatment
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Parkinson disease patients who are in stage 1 to 3 (HY) at the on period.
2)Not change taking medications within 3 months before starting this study.
3) Subjects who gave the written informed consent.
Key exclusion criteria
1)PD-related disorders and other neurodegenrative diseases.
2) The change of medications in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shimpei Fukuda |
Organization
Meiji University of Integrative Medicine
Division name
Department of Health Promoting and Geriatric Acupuncture and Moxibustion
Zip code
Address
Hiyoshi-cho, Nantan-shi, Kyoto 629-0392, Japan
TEL
0771-72-1181
sp_fukuda@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shimpei Fukuda |
Organization
Meiji University of Integrative Medicine
Division name
Department of Health Promoting and Geriatric Acupuncture and Moxibustion
Zip code
Address
Hiyoshi-cho, Nantan-shi, Kyoto 629-0392, Japan
TEL
0771-72-1181
Homepage URL
sp_fukuda@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji University of Integrative 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
| 2016 | Year | 08 | Month | 31 | 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
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 31 | Day |
Last modified on
| 2016 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027486
