Condition category
Mental and Behavioural Disorders
Date applied
18/08/2007
Date assigned
03/09/2007
Last edited
03/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes