UMIN ID: UMIN000000994
Registered date:01/07/2008
Preliminary and Exploratory Study on Specific Adverse Reactions to Acupuncture - A Randomized Controlled Trial on Tiredness, Drowsiness and Driving Ability after Treatment
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Adverse Reactions in Healthy Volunteers |
| Date of first enrollment | 2008/01/24 |
| Target sample size | 24 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Electroacupuncture Dummy electroacupuncture |
Outcome(s)
| Primary Outcome | Visual Analogue Scale (VAS) of tiredness and drowsiness, and Driving Ability Score using driving simulator |
|---|---|
| Secondary Outcome | Each item of Driving Ability Score and VAS on mood |
Key inclusion & exclusion criteria
| Age minimum | 30years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Study Group on "Safety and Efficacy of Integrative Medicine", Grant-in-Aid Scientific Research, Ministry of Health, Labour and Welfare |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Grant-in-Aid Scientific Research |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hitoshi Yamashita |
| Address | 1-26-16 Nanko-Kita, Suminoe-Ku, Osaka City Japan |
| Telephone | 06-6616-6924 |
| yamashita@morinomiya-u.ac.jp | |
| Affiliation | Morinomiya University of Medical Sciences Faculty of Health Sciences |
| scientific contact | |
| Name | Hitoshi Yamashita |
| Address | 1-26-16 Nanko-Kita, Suminoe-Ku, Osaka City Japan |
| Telephone | 06-6616-6924 |
| yamashita@morinomiya-u.ac.jp | |
| Affiliation | Morinomiya University of Medical Sciences Faculty of Health Sciences |