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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000994
Receipt No. R000001196
Scientific Title Preliminary and Exploratory Study on Specific Adverse Reactions to Acupuncture - A Randomized Controlled Trial on Tiredness, Drowsiness and Driving Ability after Treatment
Date of disclosure of the study information 2008/07/01
Last modified on 2019/02/03

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Basic information
Public title Preliminary and Exploratory Study on Specific Adverse Reactions to Acupuncture - A Randomized Controlled Trial on Tiredness, Drowsiness and Driving Ability after Treatment
Acronym Acupuncture Side Effect RCT
Scientific Title Preliminary and Exploratory Study on Specific Adverse Reactions to Acupuncture - A Randomized Controlled Trial on Tiredness, Drowsiness and Driving Ability after Treatment
Scientific Title:Acronym Acupuncture Side Effect RCT
Region
Japan

Condition
Condition Adverse Reactions in Healthy Volunteers
Classification by specialty
Medicine in general Rehabilitation medicine Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the influence of acupuncture to driving ability due to tiredness and drowsiness which are most common adverse reactions to acupuncture
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Visual Analogue Scale (VAS) of tiredness and drowsiness, and Driving Ability Score using driving simulator
Key secondary outcomes Each item of Driving Ability Score and VAS on mood

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Electroacupuncture
Interventions/Control_2 Dummy electroacupuncture
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
30 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. In good health
2. Acupuncture-naive for the past 3 years
3. Driver-licensed
Key exclusion criteria 1. Continuing medical treatments
2. Bleeding tendency, compromised, or metal allegy
3. Addictive to cigarettes, alcohol, caffeine or psychotropic
4. Carsick
5. Professional driving instructor
6. Mental diseases
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Yamashita
Organization Morinomiya University of Medical Sciences
Division name Faculty of Health Sciences
Zip code
Address 1-26-16 Nanko-Kita, Suminoe-Ku, Osaka City
TEL 06-6616-6924
Email yamashita@morinomiya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Yamashita
Organization Morinomiya University of Medical Sciences
Division name Faculty of Health Sciences
Zip code
Address 1-26-16 Nanko-Kita, Suminoe-Ku, Osaka City
TEL 06-6616-6924
Homepage URL
Email yamashita@morinomiya-u.ac.jp

Sponsor
Institute Study Group on "Safety and Efficacy of Integrative Medicine", Grant-in-Aid Scientific Research, Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization Grant-in-Aid Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 森ノ宮医療大学(大阪府)

Other administrative information
Date of disclosure of the study information
2008 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Finished.
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
2007 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 24 Day
Last follow-up date
2008 Year 01 Month 26 Day
Date of closure to data entry
2008 Year 02 Month 02 Day
Date trial data considered complete
2008 Year 02 Month 02 Day
Date analysis concluded
2008 Year 02 Month 22 Day

Other
Other related information Published only in a conference abstract so far:
Masuyama S, Yamashita H, Nakano T, Ohde S, Tokuda Y, Fukui T. Preliminary and Exploratory Study on Specific Adverse Reactions to Acupuncture - A Randomized Controlled Trial on Tiredness, Drowsiness and Driving Ability after Treatment. International Council of Medical Acupuncture and Related Techniques (ICMART) XIII World Congress. Budapest, Hungary. Oct 10-12, 2008.


Management information
Registered date
2008 Year 01 Month 24 Day
Last modified on
2019 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001196

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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