Acupuncture for Insomnia: a Randomized Controlled Trial
NCT ID: NCT02594670
Last Updated: 2015-11-03
Study Results
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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UNKNOWN
NA
333 participants
INTERVENTIONAL
2015-10-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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).
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.
DU20 and SP6 combination
combination of two acupoints based on location and Spleen meridian, including Baihui (DU20) and Sanyinjiao(SP6).
DU20 and SP6 combination
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.
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.
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.
DU20 and SP6 combination
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 Baihui (DU20) and a Sham acupoint (SA), which should have least clinical efficacy among these three types of acupoints combinations.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Ministry of Science and Technology of the People´s Republic of China
OTHER_GOV
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
OTHER
Responsible Party
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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
First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
Hengyang hospital of Hunan University of Chinese Medicine
Hengyang, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2014CB543102-1
Identifier Type: -
Identifier Source: org_study_id
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