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A Multicenter Randomized Controlled Clinical Trial of Acupuncture in Patients with Insomnia Dependent on Benzodiazepines

A Multicenter Randomized Controlled Clinical Trial of Acupuncture in Patients with Insomnia Dependent on Benzodiazepines

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006778
Enrollment
Unknown
Registered
2022-11-14
Start date
2018-04-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benzodiazepine-dependent insomnia

Interventions

control group:placebo acupuncture+ tapering off benzodiazepines
treatment group:acupuncture+tapering off benzodiazepines

Sponsors

Fu Xing Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
24 Years to 78 Years

Inclusion criteria

Inclusion criteria: ?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.

Exclusion criteria

Exclusion criteria: ?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 %

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index(ISI);drug reduction rate of benzodiazepines;

Secondary

MeasureTime frame
discontinuation rate of benzodiazepines;Fatigue scale-14;

Countries

China

Contacts

Public ContactYing CHEN

Fu Xing Hospital,Capital Medical University

yingchen2018@sina.com18618238607

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026