The Effectiveness of Acupuncture for Insomnia

ISRCTN	ISRCTN07857866
DOI	https://doi.org/10.1186/ISRCTN07857866
Protocol serial number	096XDAA00028
Sponsor	Taipei City Hospital (Taiwan)
Funder	Taipei City Government (Taiwan)

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

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

Primary study design	Interventional
Study design	Randomized controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EAI
Study objectives	Traditional 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) studied	Insomnia
Intervention	1. Acupuncture 2. Stilnox® (non-benzodiazepines) 5 mg/day at bedtime (hs) for 4 weeks
Intervention type	Other
Primary outcome measure(s)	Pittsburgh Sleep Quality Index (PSQI) records (PSQI assessment will be carried out on a weekly basis).
Key secondary outcome measure(s)	Serious adverse events.
Completion date	31/05/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	90
Key inclusion criteria	Participants suffering from insomnia who have not taken any sleep medications associated with psychiatric disorders within 30 days.
Key exclusion criteria	1. Pregnancy 2. Central nervous system disease such as seizure disorder, cerebrovascular disease, dementia etc.
Date of first enrolment	03/08/2007
Date of final enrolment	31/05/2008

145 Zhengzhou Road

Taipei City
10341
Taiwan

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan