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

A demonstrative study to observe and evaluate acupuncture effectiveness and placebo effect: taking mixed urinary incontinence and primary insomnia as examples

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041893
Enrollment
Unknown
Registered
2021-01-09
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-30

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

Conditions

Primary insomnia

Interventions

Sponsors

Institute of Acupuncture and Moxibustion, CACMS
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Spiegel Sleep Questionnaire;

Secondary

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

Countries

China

Contacts

Public ContactZhang Yanhong

Institute of Acupuncture and Moxibustion, CACMS

dalifortune@126.com+86 13426115988

Outcome results

None listed

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