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Trial record 1 of 1 for:    NCT02448602
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Different Acupoints Compatibility Difference of the Effect of Treatment of the Primary Insomnia

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ClinicalTrials.gov Identifier: NCT02448602
Recruitment Status : Unknown
Verified May 2015 by Tie Li, Changchun University of Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : May 19, 2015
Last Update Posted : May 21, 2015
Sponsor:
Collaborators:
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Hengyang Traditional Chinese Medicine Hospital
Second People's Hospital of Hunan
Jilin University
Qilu Hospital of Shandong University
Information provided by (Responsible Party):
Tie Li, Changchun University of Chinese Medicine

Tracking Information
First Submitted Date  ICMJE April 14, 2015
First Posted Date  ICMJE May 19, 2015
Last Update Posted Date May 21, 2015
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
Pittsburgh sleep quality index(PSQI) [ Time Frame: 9 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
  • Test GABA,Glu,5-HT,Ach,NE,DA in the human brain to reflect the state of brain function by the Encephalofluctuograph(ET) [ Time Frame: 5 weeks ]
  • Change in Total Sleep Time Measured by PSG [ Time Frame: 5 weeks ]
    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).
  • Sleep diary [ Time Frame: 5 weeks ]
  • Athens insomnia scale [ Time Frame: 9 weeks ]
  • Self-rating anxiety scale(SAS) [ Time Frame: 1 week ]
  • Self-Rating Depression Scale(SDS) [ Time Frame: 1 week ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Different Acupoints Compatibility Difference of the Effect of Treatment of the Primary Insomnia
Official Title  ICMJE Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Primary Insomnia
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Single point group (Shenmen)
    Patients will be acupuncture with Shenmen(HT7).
    Intervention: Other: acupuncture
  • Sancai coordinated points group
    Patients in Sancai coordinated points group, will be acupuncture with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6).
    Intervention: Other: acupuncture
  • Control group
    Patients in Control group, will be acupuncture with at the junction of deltoid and biceps.
    Intervention: Other: acupuncture
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 19, 2015)
333
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2015)
332
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02448602
Other Study ID Numbers  ICMJE ChangchunUCM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tie Li, Changchun University of Chinese Medicine
Study Sponsor  ICMJE Changchun University of Chinese Medicine
Collaborators  ICMJE
  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • Hengyang Traditional Chinese Medicine Hospital
  • Second People's Hospital of Hunan
  • Jilin University
  • Qilu Hospital of Shandong University
Investigators  ICMJE
Study Chair: Fuchun Wang, master Dean
PRS Account Changchun University of Chinese Medicine
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP