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

Primary Insomnia Clinical Trial

Official title:

Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02448602
• Other study ID #: ChangchunUCM
• Status: Recruiting
• Phase: Phase 1
• First received: April 14, 2015
• Last updated: May 20, 2015
• Start date: January 2015
• Est. completion date: August 2018

Study information

• Verified date: May 2015
• Source: Changchun University of Chinese Medicine
• Contact: Tie Li, Ph.D
• Phone: +86 0431 86714973
• Email: zusanli_1999[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 333
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	The Affiliated Hospital To Changchun University of Chinese Medicine	Changchun	Jilin

Sponsors (6)

Lead Sponsor	Collaborator
Changchun University of Chinese Medicine	Hengyang Traditional Chinese Medicine Hospital, Jilin University, Qilu Hospital, Second People's Hospital of Hunan, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh sleep quality index(PSQI)		9 weeks	No
Secondary	Test GABA,Glu,5-HT,Ach,NE,DA in the human brain to reflect the state of brain function by the Encephalofluctuograph(ET)		5 weeks	No
Secondary	Change in Total Sleep Time Measured by PSG	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	No
Secondary	Sleep diary		5 weeks	No
Secondary	Athens insomnia scale		9 weeks	No
Secondary	Self-rating anxiety scale(SAS)		1 week	No
Secondary	Self-Rating Depression Scale(SDS)		1 week	No