UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000994 |
|---|---|
| Receipt number | 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 11:32:03 |
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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
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
yamashita@morinomiya-u.ac.jp
Sponsor or person
Institute
Study Group on "Safety and Efficacy of Integrative Medicine", Grant-in-Aid Scientific Research, Ministry of Health, Labour and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
