UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of acupuncture treatment on stress in patients with Parkinson's disease.
Title of the study (Brief title)	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	Shimpei Fukuda
Organization	Meiji University of Integrative Medicine
Division name	Department of Health Promoting and Geriatric Acupuncture and Moxibustion
Address	Hiyoshi-cho, Nantan-shi, Kyoto 629-0392, Japan
TEL	0771-72-1181
Email	sp_fukuda@meiji-u.ac.jp

Public contact
Name of contact person	Shimpei Fukuda
Organization	Meiji University of Integrative Medicine
Division name	Department of Health Promoting and Geriatric Acupuncture and Moxibustion
Address	Hiyoshi-cho, Nantan-shi, Kyoto 629-0392, Japan
TEL	0771-72-1181
Homepage URL
Email	sp_fukuda@meiji-u.ac.jp

Sponsor
Institute	Meiji University of Integrative Medicine
Institute
Department

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027486