A Multicenter Randomized Controlled Clinical Trial of Acupuncture in Patients with Insomnia Dependent on Benzodiazepines
- Conditions
- benzodiazepine-dependent insomnia
- Registration Number
- ITMCTR2200006778
- Lead Sponsor
- Fu Xing Hospital,Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
?Meet the diagnostic criteria of non-organic insomnia ( F51.0 ) according to the diagnostic criteria of ICD-10 and the diagnostic criteria of hypnotic drug-dependent sleep disorder
?Age over 18
?Taking one or more benzodiazepines, using benzodiazepines in =50% of days for more than 3 months, dosage ( converted to diazepam ) =10 mg
?The patient himself signed the informed consent.
?Patients with psychosis or psychotic symptoms
?Hospital Anxiety and Depression Scale(HADS)score =8
?Patients with secondary insomnia caused by systemic diseases such as pain, fever, cough, surgery, and external environmental disturbance
?Patients with a history of material dependence, including those with tobacco and alcohol dependence
?Patients with severe organ diseases such as heart,lung,liver and kidney.Pregnant or lactating women
?Patients who received acupuncture treatment of insomnia in the past month
?The days of taking medicine in the record table of 14-day benzodiazepines before the baseline were less than 50 %
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insomnia Severity Index(ISI);drug reduction rate of benzodiazepines;
- Secondary Outcome Measures
Name Time Method discontinuation rate of benzodiazepines;Fatigue scale-14;