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

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

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

Study Locations

    • Hunan
      • Changsha, Hunan, China, 410005
        • Second Hospital of Hunan University of Chinese Medicine
      • Changsha, Hunan, China, 410007
        • First Hospital of Hunan University of Chinese Medicine
      • Hengyang, Hunan, China
        • Hengyang hospital of Hunan University of Chinese Medicine

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

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
4 weeks and 8 weeks
Short Form 36-item Health Survey(SF-36)
Time Frame: 4 weeks and 8 weeks
4 weeks and 8 weeks
Self-anxiety scale (SAS)
Time Frame: 4 weeks and 8 weeks
4 weeks and 8 weeks
Self-depression scale (SDS)
Time Frame: 4 weeks and 8 weeks
4 weeks and 8 weeks

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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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