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

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

PHASE1

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Single point group (Shenmen)

Patients will be acupuncture with Shenmen(HT7).

Group Type OTHER

acupuncture

Intervention Type OTHER

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.

Sancai coordinated points group

Patients in Sancai coordinated points group, will be acupuncture with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6).

Group Type OTHER

acupuncture

Intervention Type OTHER

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.

Control group

Patients in Control group, will be acupuncture with at the junction of deltoid and biceps.

Group Type OTHER

acupuncture

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

* Caused by excessive anxiety and depression of patients with insomnia.

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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No