Acupuncture for Insomnia: a Randomized Controlled Trial (AI-RCT)

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Status: Unknown

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Other: DU20 and SP6 combination; Other: DU20 and HT7 combination; Other: DU20 and SA combination

Study type: Interventional

Funder types: Other

Identifiers

NCT02594670

2014CB543102-1

Details and patient eligibility

About

Selecting different acupoints as an combination of acupoints is a key factor to clinical efficacy of acupuncture. Different combinations of acupoints will generate different clinical efficacy. So,the purpose of this study is to determine the different clinical efficacy among three types of combinations of acupoints in the treatment of primary insomnia.

Enrollment: 333 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed as insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,2013, American psychiatric association
• PSQI score >7
• AIS score ≥6
• SDS ≤60
• SAS ≤60
• Age between 18 and 65 years old
• Not involved in other clinical trial in the lasted 6 months before screening
• Have the ability to write the informed consent.

Exclusion criteria

• Breathing-related sleep disorders
• Circadian rhythm sleep-wake disorders
• Medication-induced sleep disorder
• Substance induced sleep disorders,such as alcohol, coffee, strong tea
• Secondary insomnia caused by systemic diseases or caused by external environment disturbance
• Pregnant or lactating women
• Combined with serious cardiovascular, lung, liver, kidney, hematopoietic system, and mental diseases
• Advanced malignant tumor or other serious debilitating diseases
• Location of acupoints combined with infection and bleeding
• Declined to acupuncture
• Couldn't provide the written informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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333 participants in 3 patient groups

DU20 and HT7 combination

Experimental group

Description:

combination of two acupoints based on location and Heart meridian, including Baihui (DU20) and Shenmen(HT7).

Treatment:

Other: DU20 and HT7 combination

DU20 and SP6 combination

Other group

Description:

combination of two acupoints based on location and Spleen meridian, including Baihui (DU20) and Sanyinjiao(SP6).

Treatment:

Other: DU20 and SP6 combination

DU20 and SA combination

Sham Comparator group

Description:

combination of local acupoint Baihui (DU20) and a sham acupoint (SA) not belonging to any regular meridian or acupoint.

Treatment:

Other: DU20 and SA combination