A comparative study on the therapeutic effect and placebo effect of acupuncture on primary insomnia

Phase 1

Recruiting

• Conditions: Primary insomnia

• Registration Number: ITMCTR2100004657
• Lead Sponsor: Institute of Acupuncture and Moxibustion, CACMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Sign the informed consent;
(2) Between the ages of 15 and 65, for both men and women;
(3) Subacute or chronic insomnia with a course >= 1 month;
(4) Primary insomnia (except familial fatal insomnia);
(5) Spiegel Sleep questionnaire, patients' sleep status in the past week, with a total score of >= 9 points.

Exclusion Criteria

(1) Insomnia caused by anxiety disorder (SAS score >= 50);
(2) Insomnia caused by depression (BDI score >= 14);
(3) Other secondary insomnia, or insomnia caused by physical diseases (such as stroke, Parkinson's disease, etc.);
(4) Participating in other clinical studies;
(5) pregnant or lactating women, or preparing for pregnancy in the course of medical treatment;
(6) According to the judgment of the researchers, the patients are vulnerable to loss due to other pathological conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes of work and unstable living environment.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spiegel Sleep Questionnaire;

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory, BDI;Insomnia Severity Index, ISI;Self-Rating Anxiety Scale, SAS;Pittsburgh Sleep Quality Index, PSQI;