Electro-acupuncture for treating the treatment-resistant insomnia : randomized controlled, assessor-blinded, pilot clinical trial

Pusan National University Korean Medicine Hospital0 sites50 target enrollmentTBD

ConditionsMental and behavioural disorders

Overview

Phase: 未知
Intervention: Not specified
Conditions: Mental and behavioural disorders
Sponsor: Pusan National University Korean Medicine Hospital
Enrollment: 50
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 24, 2020

Last Updated

4 years ago

Study Type

Interventional Study

Sex

All

Investigators

Sponsor

Pusan National University Korean Medicine Hospital

Eligibility Criteria

Inclusion Criteria

•1\. Patients aged 19 years \- 80 years
•2\. Patinets who continous taking medication for improving insomnia symptoms over the last 3 months, and not changed their regular medication type or doseage to improve insomnia within the last 2 weeks
•3\. Total score in the Insomnia Severity Index (ISI)\=15 points
•4\. fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM\-5\) diagnostic criteria for insomnia disorder
•5\. Willingness to participate in the trial and having provided written consent

Exclusion Criteria

•1\. Having undergone Korean medical treatment (eg, acupuncture, moxibustion, cupping, herbal medicine) within last 2 weeks for improving insomnia
•2\. Initiation the dietary supplement regimen or non\-pharmacological therapies (eg, cognitive behavioural therapy, meditation, etc) to alleviate insomnia within the last 2 weeks or plans for initiation during the trial.
•3\. The patients with unstable(not controlled) schizophrenia, mania, bipolar disorder within last 6 months, or a subscale of either anxiety or depression in Hamilton Anxiety and Depression Scale score \=11 points
•4\. The patients with substance abuse/dependence within last 6 months
•5\. Having experienced suicide/murder/self\-injury attempt
•6\. Working shifts or changes in day/night work schedule that could impact circadian rhythm
•7\. Suffering from pain severe enough to cause sleep disturbance or presence of any disease that could cause insomnia
•8\. Taking haemostatic agents (eg, Greenmono, Advate, Monoclate\-P, Facnyne, BeneFix) because of cardiovascular or haemostatic disorders
•9\. Abnormal findings in thyroid function test (abnormal level of free thyroxine (free T4\) and thyroid\-stimulating hormone (TSH) \<0\.1 µIU/mL or TSH \>5\.1 µIU/mL)
•10\. Inadequate findings in laboratory test(total bilirubin\> 2 times compared to the normal upper limit in research institute, ALT(Alanine transaminase) or AST(Aspartate transaminase) \> 2\.5 times compared to the normal upper limit in research institute, Creatinine \> 2\.5 times compared to the normal upper limit in research institute, WBC count \< 1,500 ? or \=10,000 ?, Absolute Neutrophil Count(ANC)\< 1,000, platelets count \< 75,000/µL, positive in urine HCG, or other abnormal findings that could impact the trial by investigator’s decision)