NCT02087488

Auricular Acupuncture for Primary Insomnia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Chengdu University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Investigators will conduct a 2-year clinical trial on auricular acupuncture (AA) for primary insomnia (PI), which is a double-blind (patient-blind and assessor-blind) RCT. 288 patients will be randomly assigned into 2 groups: the treatment group (Group A) and the control group (Group B). Group A will be treated with AA plus oral Eszopiclone, while Group B will be treated with sham AA plus oral Eszopiclone. All patients will receive a continuous 4-week treatment and 28-week follow-up. The data will be analyzed by the third party who is not clear about allocation and treatment.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-12-01
• Completion: 2016-06-01
• First posted: 2014-03-14
• Last updated: 2020-02-17

Locations

1 site across 1 country: China