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Acupuncture treating chronic insomnia: A randomised, patient-assessor-blinded, placebo-controlled clinical trial

Acupuncture treating chronic insomnia: A randomised, patient-assessor-blinded, placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089787
Enrollment
Unknown
Registered
2024-09-14
Start date
2024-05-29
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Insomnia

Interventions

Acupuncture:Participants will receive 21 sessions of acupuncture over 8 weeks, 30 minutes per session.
Placebo acupuncture:Blunt placebo needles of stainless steel will be used, with participants receive 21 sessions of acupuncture over 8 weeks, 30 minutes per session.

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1)Meet the diagnostic criteria for insomnia disorder in DSM-5 2) Insomnia Severity Index score =8 3)18= age =65 years old, both female and male 4)Voluntarily participate in this trial and sign the informed consent form

Exclusion criteria

Exclusion criteria: (1)Having insomnia caused by organic diseases or use of psychotropic substances; (2)Allergy to the acupuncture needle used in this trial; (3)Having skin damage near acupoints or is inability to receive acupuncture due to other reasons; (4)Pregnant or lactating women; (5)Participant with severe diseases such as respiratory, cardiovascular, endocrine, hematological disorders, liver or kidney dysfunction, or tumors; (6)Participant with suicidal tendencies or history of suicide attempts; (7)Alcohol and drug abusers; (8)Participant who have participated in other clinical trials in the past 3 months; (9)Other conditions considered invalid to participate in the trial by researchers

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index ;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index;Sleep Diary;Actigraphy;

Countries

China

Contacts

Public ContactWenjing Zhang

Shanghai Municipal Hospital of Traditional Chinese Medicine

zhangwenjing@shutcm.edu.cn+86 186 1636 0246

Outcome results

None listed

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