insomnia
Conditions
Interventions
Acupuncture group:Acupuncture at 4 points: Baihui, Shenmen, Neiguan and Taichong,Treatment once a day, each time to leave the needle 30min, 6 times a week, a total of 4 weeks of treatment.
Western medicine group:Oral dexzopiclone,1-2mg/dose once/day at bedtime for 4 weeks.
Sponsors
Affiliated Hospital of Gansu University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Those who meet the DSM-5 diagnostic criteria for primary insomnia in Western medicine; (2) Those who meet the Chinese medicine diagnostic criteria for liver-depression-type insomnia; (3) Of either sex, right-handed, and between the ages of 18 and 60; (4) The duration of the disease is between 3 months and 5 years; (5) Pittsburgh Sleep Quality Index (PSQI) > 7; (6) The degree of insomnia was judged to be that of a patient with mild to moderate insomnia, i.e., a score of =12 and =18 on the international generalised SPIEGEL scale; (7) Hamilton Depression Scale (HAMD) 17-item total score: 7 points = HAMD total score = 20 points; Hamilton Anxiety Scale (HAMA) 14-item total score: 7 points = HAMD total score = 14 points; (8) Not receiving insomnia-related treatments such as drugs or acupuncture in the past six months; (9) Voluntarily filled out the informed consent form and agreed to participate in the clinical subjects.
Exclusion criteria
Exclusion criteria: (1) Concomitant with severe underlying diseases, such as malignant tumors, heart, liver, and kidney dysfunction, systemic malnutrition, and rheumatic immune diseases; (2) Insomnia caused by drugs or alcohol; (3) Concomitant mental illnesses such as severe depression, anxiety, and bipolar disorder; (4) Inability to tolerate estazolam; (5) Participate in other clinical trials at the same time; (6) Acupuncture treatment is not recommended for symptoms with spontaneous bleeding tendencies or persistent bleeding after injury (such as thrombocytopenic purpura, leukemia, hemophilia, etc.) and local skin infections. (7) Patients are unwilling or unable to cooperate in completing the experiment as required;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index(PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale(HAMD)Hamilton Anxiety Scale(HAMA)Fatigue Scale-14(FS-14);fractional Amplitude of low frequency fluctuation(fALFF);Functional Connectivity(FC) ;Graph theory analysis(GTA); | — |
Countries
China
Contacts
Public ContactYe Yujuan
Gansu University of Traditional Chinese medicine
Outcome results
None listed