Acupuncture for Insomnia: a Randomized Controlled Trial

NCT ID: NCT02594670

Last Updated: 2015-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DU20 and HT7 combination

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

Group Type EXPERIMENTAL

DU20 and HT7 combination

Intervention Type OTHER

acupoints combination includes Baihui (DU20) and Shenmen(HT7),which was considered as the optimal clinical efficay among various combinations of acupoints.

DU20 and SP6 combination

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

Group Type OTHER

DU20 and SP6 combination

Intervention Type OTHER

acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.

DU20 and SA combination

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

Group Type SHAM_COMPARATOR

DU20 and SA combination

Intervention Type OTHER

Combination of Baihui (DU20) and a Sham acupoint (SA), which should have least clinical efficacy among these three types of acupoints combinations.

Interventions

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DU20 and HT7 combination

acupoints combination includes Baihui (DU20) and Shenmen(HT7),which was considered as the optimal clinical efficay among various combinations of acupoints.

Intervention Type OTHER

DU20 and SP6 combination

acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.

Intervention Type OTHER

DU20 and SA combination

Combination of Baihui (DU20) and a Sham acupoint (SA), which should have least clinical efficacy among these three types of acupoints combinations.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

Sponsor Role collaborator

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zenghui Yue

Role: STUDY_CHAIR

Hunan University of Chinese Medicine

Locations

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Second Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China

Site Status

First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China

Site Status

Hengyang hospital of Hunan University of Chinese Medicine

Hengyang, Hunan, China

Site Status

Countries

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China

Central Contacts

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Yan Wang

Role: CONTACT

Facility Contacts

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Zenghui Yue

Role: primary

Other Identifiers

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2014CB543102-1

Identifier Type: -

Identifier Source: org_study_id

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