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Auricular Acupuncture for Primary Insomnia

NCT02087488 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2020-02-17

No results posted yet for this study

Summary

This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular acupuncture(AA) for primary insomnia(PI) .

Conditions

  • Primary Insomnia

Interventions

OTHER

auricular acupuncture(AA)

Auricular acupoints: Shenmen (TF4), Heart (CO15), Subcortex (AT4), modifying points according to different patterns. Auricular attachment material: disposable Seirin Pyonex Needle Seirin Pyonex Needle manufacturer: Seirin Corporation, a Japanese company. Medical Device Certification number: No. 15500BZZ00806000. Treatment frequency: every 3 days. Duration: 4 weeks.

OTHER

placebo AA

Auricular acupoints: Wrist (SF1), Clavicle (SF6), Shoulder (SF4、5), Tooth (LO1), Tonsil (LO7, 8, 9). Auricular attachment material: the disposable Pyonex Zero Needle Pyonex Zero Needle manufacturer: Seirin Corporation, a Japanese company. Treatment frequency: every 3 days. Duration: 4 weeks.

DRUG

Eszopiclone

Dosage form: tablet. Dosage: 1 piece (3mg). Drug manufacturer: Kanghong pharmaceutical limited liability company, Chengdu. Production license: NO. H20100074 approved by the state. Treatment frequency: 15 mins before going to bed everyday. Duration: 4 weeks.

Sponsors & Collaborators

  • Chengdu University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Fanrong Liang, Professor · Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine

  • Xi Wu, A.P. · Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-12-31
Completion
2016-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02087488 on ClinicalTrials.gov