Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT00839592
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00839592
Study Brief:
Protocol Section:
NCT00839592