- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02594670
Acupuncture for Insomnia: a Randomized Controlled Trial (AI-RCT)
November 2, 2015 updated by: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Acupuncture Based on Different Acupoints Combination for Insomnia: a Randomized Controlled Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
333
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yan Wang
- Email: 48770045@qq.com
Study Locations
-
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Hunan
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Changsha, Hunan, China, 410005
- Second Hospital of Hunan University of Chinese Medicine
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Changsha, Hunan, China, 410007
- First Hospital of Hunan University of Chinese Medicine
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Hengyang, Hunan, China
- Hengyang hospital of Hunan University of Chinese Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DU20 and HT7 combination
combination of two acupoints based on location and Heart meridian, including Baihui (DU20) and Shenmen(HT7).
|
acupoints combination includes Baihui (DU20) and Shenmen(HT7),which was considered as the optimal clinical efficay among various combinations of acupoints.
|
Other: DU20 and SP6 combination
combination of two acupoints based on location and Spleen meridian, including Baihui (DU20) and Sanyinjiao(SP6).
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acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.
|
Sham Comparator: DU20 and SA combination
combination of local acupoint Baihui (DU20) and a sham acupoint (SA) not belonging to any regular meridian or acupoint.
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Combination of Baihui (DU20) and a Sham acupoint (SA), which should have least clinical efficacy among these three types of acupoints combinations.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pittsburgh sleep quality index (PSQI)
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Athens Insomnia Scale (AIS)
Time Frame: 4 weeks and 8 weeks
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4 weeks and 8 weeks
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Short Form 36-item Health Survey(SF-36)
Time Frame: 4 weeks and 8 weeks
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4 weeks and 8 weeks
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Self-anxiety scale (SAS)
Time Frame: 4 weeks and 8 weeks
|
4 weeks and 8 weeks
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Self-depression scale (SDS)
Time Frame: 4 weeks and 8 weeks
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4 weeks and 8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety evaluation will summarize the incidence of adverse events,including itching and redness of local acupoints.
Time Frame: 4 weeks
|
4 weeks
|
|
adherence of acupuncture
Time Frame: 4 weeks
|
adherence to the treatment (adherence rate)will be calculated using formula: Adherence Rate = Number of Treatment Conducted/ Number of Treatment Planned
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4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Zenghui Yue, Hunan University of Chinese Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
August 1, 2017
Study Registration Dates
First Submitted
September 30, 2014
First Submitted That Met QC Criteria
November 2, 2015
First Posted (Estimate)
November 3, 2015
Study Record Updates
Last Update Posted (Estimate)
November 3, 2015
Last Update Submitted That Met QC Criteria
November 2, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014CB543102-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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