Different Acupoints Compatibility Difference of the Effect of Treatment of the Primary Insomnia
Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect
1 other identifier
interventional
333
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 14, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedMay 21, 2015
May 1, 2015
2.9 years
April 14, 2015
May 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pittsburgh sleep quality index(PSQI)
9 weeks
Secondary Outcomes (6)
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
Change in Total Sleep Time Measured by PSG
5 weeks
Sleep diary
5 weeks
Athens insomnia scale
9 weeks
Self-rating anxiety scale(SAS)
1 week
- +1 more secondary outcomes
Study Arms (3)
Single point group (Shenmen)
OTHERPatients will be acupuncture with Shenmen(HT7).
Sancai coordinated points group
OTHERPatients in Sancai coordinated points group, will be acupuncture with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6).
Control group
OTHERPatients in Control group, will be acupuncture with at the junction of deltoid and biceps.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- Caused by excessive anxiety and depression of patients with insomnia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changchun University of Chinese Medicinelead
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicinecollaborator
- Hengyang Traditional Chinese Medicine Hospitalcollaborator
- Second People's Hospital of Hunancollaborator
- Jilin Universitycollaborator
- Qilu Hospital of Shandong Universitycollaborator
Study Sites (1)
The Affiliated Hospital To Changchun University of Chinese Medicine
Changchun, Jilin, 130117, China
Related Publications (3)
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.
PMID: 34918637DERIVEDShi 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.
PMID: 33146953DERIVEDWang 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.
PMID: 32807158DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fuchun Wang, master
Dean
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- 973 project management deputy director of the office
Study Record Dates
First Submitted
April 14, 2015
First Posted
May 19, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2017
Study Completion
August 1, 2018
Last Updated
May 21, 2015
Record last verified: 2015-05