Contact information
Type
Scientific
Primary contact
Dr Yu-Yang Chiang
ORCID ID
Contact details
145 Zhengzhou Road
Datong District
Taipei City
10341
Taiwan
+886 2 25523234 ext 5207
chiang3940@yahoo.com.tw
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
096XDAA00028
Study information
Scientific title
Acronym
EAI
Study hypothesis
Traditional Chinese Medicine (TCM) Meridian Theory.
Ethics approval
Approved by the Institutional Review Board at Taipei City Hospital (IRB/TCH) (ref: 960302)
Study design
Randomized controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Insomnia
Intervention
1. Acupuncture
2. Stilnox® (non-benzodiazepines) 5 mg/day at bedtime (hs) for 4 weeks
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Pittsburgh Sleep Quality Index (PSQI) records (PSQI assessment will be carried out on a weekly basis).
Secondary outcome measures
Serious adverse events.
Overall trial start date
03/08/2007
Overall trial end date
31/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Participants suffering from insomnia who have not taken any sleep medications associated with psychiatric disorders within 30 days.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Pregnancy
2. Central nervous system disease such as seizure disorder, cerebrovascular disease, dementia etc.
Recruitment start date
03/08/2007
Recruitment end date
31/05/2008
Locations
Countries of recruitment
Taiwan
Trial participating centre
145 Zhengzhou Road
Taipei City
10341
Taiwan
Sponsor information
Organisation
Taipei City Hospital (Taiwan)
Sponsor details
145 Zhengzhou Road
Datong District
Taipei City
10341
Taiwan
+886 2 25523234
chiang3940@yahoo.com.tw
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Taipei City Government (Taiwan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary