ISRCTN ISRCTN07857866
DOI https://doi.org/10.1186/ISRCTN07857866
Secondary identifying numbers 096XDAA00028
Submission date
18/08/2007
Registration date
03/09/2007
Last edited
03/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Yu-Yang Chiang
Scientific

145 Zhengzhou Road
Datong District
Taipei City
10341
Taiwan

Phone +886 2 25523234 ext 5207
Email chiang3940@yahoo.com.tw

Study information

Study designRandomized controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymEAI
Study objectivesTraditional Chinese Medicine (TCM) Meridian Theory.
Ethics approval(s)Approved by the Institutional Review Board at Taipei City Hospital (IRB/TCH) (ref: 960302)
Health condition(s) or problem(s) studiedInsomnia
Intervention1. Acupuncture
2. Stilnox® (non-benzodiazepines) 5 mg/day at bedtime (hs) for 4 weeks
Intervention typeOther
Primary outcome measurePittsburgh Sleep Quality Index (PSQI) records (PSQI assessment will be carried out on a weekly basis).
Secondary outcome measuresSerious adverse events.
Overall study start date03/08/2007
Completion date31/05/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants90
Key inclusion criteriaParticipants suffering from insomnia who have not taken any sleep medications associated with psychiatric disorders within 30 days.
Key exclusion criteria1. Pregnancy
2. Central nervous system disease such as seizure disorder, cerebrovascular disease, dementia etc.
Date of first enrolment03/08/2007
Date of final enrolment31/05/2008

Locations

Countries of recruitment

  • Taiwan

Study participating centre

145 Zhengzhou Road
Taipei City
10341
Taiwan

Sponsor information

Taipei City Hospital (Taiwan)
Hospital/treatment centre

145 Zhengzhou Road
Datong District
Taipei City
10341
Taiwan

Phone +886 2 25523234
Email chiang3940@yahoo.com.tw
ROR logo "ROR" https://ror.org/02gzfb532

Funders

Funder type

Not defined

Taipei City Government (Taiwan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan