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Acupuncture for insomnia with short sleep duration: a randomized controlled trial

Phase 1
Conditions
insomnia
Registration Number
ITMCTR1900002372
Lead Sponsor
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Aged 18 to 65 years, male or female;
(2) Compliance with the diagnostic criteria for chronic insomnia in ICSD-3;
(3) Stable administration of sedative-hypnotic drugs for more than 3 months before entering the study or not taken such drugs, and did not participate in other insomnia research;
(4) PSQI> 5 points, ISI> 14 points, BAI< 45 points and BDI = 28 points;
(5) Never received acupuncture treatment;
(6) Voluntarily participated in the study and signed informed consent.

Exclusion Criteria

(1) Severe hepatic and renal function damage, as well as hematologic diseases and respiratory diseases and diagnosis of the mental disorders according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) [34];
(2) Semi-structured clinical interviews determined subjects as other sleep disorders rather than primary insomnia;
(3) Subjects with infectious diseases such as infectious hepatitis, tuberculosis, AIDS, syphilis,etc.;
(4) Severe digestive system diseases and severe malnutrition;
(5) Pregnant or lactating women;
(6) Subjects with severe trauma and not cured or other subjects not suitable for acupuncture, such as: allergic constitution, patients with severe dermatosis;
(7) Participated in other clinical trials in the last 3 months.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ISI scale;PSQI scale;
Secondary Outcome Measures
NameTimeMethod
BAI scale;ACT;FSS scale;BDI scale;
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