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

Primary Purpose

Primary Insomnia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
acupuncture
acupuncture
acupuncture
Sponsored by
Changchun University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia focused on measuring Different acupoints compatibility

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Affiliated Hospital To Changchun University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Single point group (Shenmen)

Sancai coordinated points group

Control group

Arm Description

Patients will be acupuncture with Shenmen(HT7).

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

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

Outcomes

Primary Outcome Measures

Pittsburgh sleep quality index(PSQI)

Secondary Outcome Measures

Test GABA,Glu,5-HT,Ach,NE,DA in the human brain to reflect the state of brain function by the Encephalofluctuograph(ET)
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).
Sleep diary
Athens insomnia scale
Self-rating anxiety scale(SAS)
Self-Rating Depression Scale(SDS)

Full Information

First Posted
April 14, 2015
Last Updated
May 20, 2015
Sponsor
Changchun University of Chinese Medicine
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
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1. Study Identification

Unique Protocol Identification Number
NCT02448602
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changchun University of Chinese Medicine
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
Different acupoints compatibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
333 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single point group (Shenmen)
Arm Type
Other
Arm Description
Patients will be acupuncture with Shenmen(HT7).
Arm Title
Sancai coordinated points group
Arm Type
Other
Arm Description
Patients in Sancai coordinated points group, will be acupuncture with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6).
Arm Title
Control group
Arm Type
Other
Arm Description
Patients in Control group, will be acupuncture with at the junction of deltoid and biceps.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pittsburgh sleep quality index(PSQI)
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
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
Title
Change in Total Sleep Time Measured by PSG
Description
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).
Time Frame
5 weeks
Title
Sleep diary
Time Frame
5 weeks
Title
Athens insomnia scale
Time Frame
9 weeks
Title
Self-rating anxiety scale(SAS)
Time Frame
1 week
Title
Self-Rating Depression Scale(SDS)
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tie Li, Ph.D
Phone
+86 0431 86714973
Email
zusanli_1999@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuchun Wang, master
Organizational Affiliation
Dean
Official's Role
Study Chair
Facility Information:
Facility Name
The Affiliated Hospital To Changchun University of Chinese Medicine
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tie Li, Ph.D
Phone
+86 0431 86714973
Email
zusanli_1999@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34918637
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.
Results Reference
derived
PubMed Identifier
33146953
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.
Results Reference
derived
PubMed Identifier
32807158
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.
Results Reference
derived

Learn more about this trial

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

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