Status:
COMPLETED
Acupuncture for Primary Insomnia
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Hong Kong Baptist University
Hong Kong Professional Teachers' Union
Conditions:
Insomnia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a randomized controlled trial to evaluate acupuncture treatment on insomnia in the adult population in Hong Kong.
Detailed Description
Acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment on primary insomnia. This is ...
Eligibility Criteria
Inclusion
- Hong Kong residents
- aged 18-65
- Ethnic Chinese
- Meet the diagnosis criteria of primary insomnia for at least 3 months according to DSM-IV using the Structured Clinical Interview for DSM-IV (SCID)
- Willing to give informed consent
- total score of Insomnia Severity Index (ISI) at least 15
- Able to comply with trial protocol
Exclusion
- Participation in any clinical trial during the previous 3 months prior to baseline
- Any current major depressive disorder, generalized anxiety disorders or panic disorder, manic or hypomanic episode, substance use disorders besides caffeine and nicotine, organic mental disorder, schizophrenia or any other psychotic disorder as defined by DSM-IV criteria
- Serious physical illness or mental disorders due to a general medical condition which is judged by the investigator to render unsafe
- Valvular heart defects, bleeding disorders or taking anticoagulant drugs.
- Any acupuncture treatment during the previous 12 months prior to baseline.
- In the investigator's opinion, the patient has a significant risk of suicide
- Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
- Infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
- Herbal remedies, over-the-counter medications or psychotropic drugs, which are intended for insomnia, were taken within the last 2 weeks prior to baseline or during the study
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00839592
Start Date
July 1 2006
End Date
April 1 2007
Last Update
January 14 2010
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong