UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preliminary and Exploratory Study on Specific Adverse Reactions to Acupuncture - A Randomized Controlled Trial on Tiredness, Drowsiness and Driving Ability after Treatment
Title of the study (Brief title)	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	Hitoshi Yamashita
Organization	Morinomiya University of Medical Sciences
Division name	Faculty of Health Sciences
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	Hitoshi Yamashita
Organization	Morinomiya University of Medical Sciences
Division name	Faculty of Health Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 12 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Finished.
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/icdr_e/ctr_view.cgi?recptno=R000001196