Different Acupoints Compatibility Difference of the Effect of Treatment of the Primary Insomnia

May 20, 2015 updated by: Tie Li, Changchun University of Chinese Medicine

Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect

With primary insomnia as the research object, by the method of multi-center RCT and needle single cavity and different acupoints compatibility treatment for primary insomnia, to Pittsburgh sleep quality index(PSQI) and evaluation, sleep log evaluation and Polysomnogram(PSG) as the means, such as the single cavity with different acupoints compatibility evaluate clinical curative effect of treating primary insomnia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In order to establish a spectrum of acupoints compatibility of the law, is clear about the factors affecting the compatibility effect of acupoints, the formation of strong operability of acupoints compatibility optimization evaluation method, the project choice of the clinical acupuncture and moxibustion have curative effect of primary insomnia as the breakthrough point of the study, carried out clinical multi-center RCT research, through objective and scientific evaluation method, comparing the effect of different acupoints compatibility.

Primary insomnia in clinical common disease, frequently-occurring disease, acupuncture curative effect is distinct, disease diagnosis, curative effect evaluation standard. Previous clinical data also show that the primary insomnia is acupuncture clinical diseases. This project by primary insomnia as the research object, research to better guide clinical practice, improve the clinical curative effect, promote acupuncture of the inheritance and innovation, promote scientification of acupuncture and moxibustion, modernization and internationalization, and will have broad prospect of application and significant scientific research value.

Study Type

Interventional

Enrollment (Anticipated)

333

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130117
        • Recruiting
        • The Affiliated Hospital To Changchun 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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Insomnia 's Disease;
  • Aged 18-60 (including 18 and 60);
  • Does not attend other clinical researchers;
  • Participation in the researchers signed informed consent and voluntary;
  • Pittsburgh sleep index (PSQI) index > 7 points;
  • Athens scale or 6 points;
  • Depression scale and anxiety scale 50 points or less.

Exclusion Criteria:

  • Breathing-Related Sleep disorder;
  • Circadian rhythm disorders;
  • Sleep disorders;
  • Drug-induced insomnia (such as drug abuse, drug treatment);
  • Sleep disorders caused by poor diet, lifestyle factors(Long-term excessive drinking, coffee, tea, etc.);
  • All systemic diseases (such as pain, fever, cough, surgery, etc.) and the external environment disturbance factors;
  • With cardiovascular, lung, liver, kidney and hematopoietic system such as serious primary diseases;
  • Patients with mental illness;
  • Pregnancy or breast-feeding women;
  • Acupoints with severe skin infections;
  • Patients who are afraid of acupuncture;
  • Advanced malignant tumor or other serious wasting disease, infection and bleeding;
  • Who do not meet the inclusion criteria, poor compliance, treatment, not according to stipulations can not judge the curative effect or data not congruent affect curative effect and safety of judgment;
  • Caused by excessive anxiety and depression of patients with insomnia.

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: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single point group (Shenmen)
Patients will be acupuncture with Shenmen(HT7).
Other: acupuncture
Patients will be treated with Shenmen(HT7), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
Other: acupuncture
Patients in Sancai coordinated points group, will be treated with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
Other: acupuncture
Patients in Control group, will be treated with at the junction of deltoid and biceps, needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
Other: Sancai coordinated points group
Patients in Sancai coordinated points group, will be acupuncture with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6).
Other: acupuncture
Patients will be treated with Shenmen(HT7), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
Other: acupuncture
Patients in Sancai coordinated points group, will be treated with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
Other: acupuncture
Patients in Control group, will be treated with at the junction of deltoid and biceps, needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
Other: Control group
Patients in Control group, will be acupuncture with at the junction of deltoid and biceps.
Other: acupuncture
Patients will be treated with Shenmen(HT7), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
Other: acupuncture
Patients in Sancai coordinated points group, will be treated with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
Other: acupuncture
Patients in Control group, will be treated with at the junction of deltoid and biceps, needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pittsburgh sleep quality index(PSQI)
Time Frame: 9 weeks
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-rating anxiety scale(SAS)
Time Frame: 1 week
1 week
Self-Rating Depression Scale(SDS)
Time Frame: 1 week
1 week
Test GABA,Glu,5-HT,Ach,NE,DA in the human brain to reflect the state of brain function by the Encephalofluctuograph(ET)
Time Frame: 5 weeks
5 weeks
Change in Total Sleep Time Measured by PSG
Time Frame: 5 weeks
Measuring indexes including total record time(TRT), sleep time(SPT), total sleep time(TST, sleep efficiency, sleep latency(SL), sleep cycle changes, awakening times, fall asleep after waking hours, REM times incubation period, incubation period of REM, REM (except the awakening times).
5 weeks
Sleep diary
Time Frame: 5 weeks
5 weeks
Athens insomnia scale
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

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

Sponsor

Changchun University of Chinese Medicine

Collaborators

Qilu Hospital of Shandong University
Jilin University
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Hengyang Traditional Chinese Medicine Hospital
Second People's Hospital of Hunan

Investigators

  • Study Chair: Fuchun Wang, master, dean

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChangchunUCM

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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