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

Changchun University of Chinese Medicine

Status and phase: Unknown; Phase 1

Conditions: Primary Insomnia

Treatments: Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02448602

ChangchunUCM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 333 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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333 participants in 3 patient groups

Single point group (Shenmen)

Other group

Description:

Patients will be acupuncture with Shenmen(HT7).

Treatment:

Other: acupuncture

Other: acupuncture

Other: acupuncture

Sancai coordinated points group

Other group

Description:

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

Treatment:

Other: acupuncture

Other: acupuncture

Other: acupuncture

Control group

Other group

Description:

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

Treatment:

Other: acupuncture

Other: acupuncture

Other: acupuncture