Clinical trial NCT02448602: Different Acupoints Compatibility Difference of the Effect of Treatment of the Primary Insomnia
Official title: Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Primary Insomnia
Keywords: Different acupoints compatibility
Lead sponsor: Changchun University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: Hengyang Traditional Chinese Medicine Hospital
name: Second People's Hospital of Hunan
name: Jilin University
name: Qilu Hospital of Shandong University
First posted: 2015-05-19
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh sleep quality index(PSQI)
timeFrame: 9 weeks
Secondary outcomes:
measure: Test GABA,Glu,5-HT,Ach,NE,DA in the human brain to reflect the state of brain function by the Encephalofluctuograph(ET)
timeFrame: 5 weeks
measure: Change in Total Sleep Time Measured by PSG
timeFrame: 5 weeks
measure: Sleep diary
timeFrame: 5 weeks
measure: Athens insomnia scale
timeFrame: 9 weeks
measure: Self-rating anxiety scale(SAS)
timeFrame: 1 week
measure: Self-Rating Depression Scale(SDS)
timeFrame: 1 week
Other outcomes:
Locations:
city: Changchun
country: China
facility: The Affiliated Hospital To Changchun University of Chinese Medicine
state: Jilin
Study officials:
affiliation: Dean
name: Fuchun Wang, master
role: STUDY_CHAIR
References:
citation: Ha L, Liu X, Liu Y, Zhi M, Jiang H, Zhao J, Wang Y, Xu X, Guo L, Cao J, Chen L, Yuan Y, Li T, Wang F. Scheme optimization of acupoints compatibility and influence factors of the effect. Medicine (Baltimore). 2021 Dec 17;100(50):e27883. doi: 10.1097/MD.0000000000027883.
citation: Shi XH, Wang YK, Li T, Liu HY, Wang XT, Wang ZH, Mang J, Xu ZX. Gender-related difference in altered fractional amplitude of low-frequency fluctuations after electroacupuncture on primary insomnia patients: A resting-state fMRI study. Brain Behav. 2021 Jan;11(1):e01927. doi: 10.1002/brb3.1927. Epub 2020 Nov 4.
citation: Wang YK, Li T, Ha LJ, Lv ZW, Wang FC, Wang ZH, Mang J, Xu ZX. Effectiveness and cerebral responses of multi-points acupuncture for primary insomnia: a preliminary randomized clinical trial and fMRI study. BMC Complement Med Ther. 2020 Aug 17;20(1):254. doi: 10.1186/s12906-020-02969-6.