Insomnia
Conditions
Interventions
Real acupuncture group:Acupoint needling with Qihuang needles
Sham acupuncture group:Non-acupoint needling with Qihuang needles
Sponsors
The fourth Clinical Medical College of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Individuals who simultaneously meet the diagnostic criteria for insomnia in Western medicine and the syndrome differentiation criteria for insomnia in Traditional Chinese Medicine. (2)Individuals aged 30 to 65 years (inclusive of 30 and 65 years) experiencing insomnia, regardless of gender. (3)Frequency of onset >3 times per week. (4)No sedatives, hypnotics, or other treatments have been administered within the past week. (5)7= Pittsburgh Sleep Quality Index (PSQI) total score < 16. (6)Individuals who have not used antibiotics within the month preceding the intervention and have not used probiotic preparations within the preceding two weeks. (7)Informed consent of the patient: The patient or their family member voluntarily signs the trial informed consent form.
Exclusion criteria
Exclusion criteria: (1)Patients with severe concomitant systemic diseases such as heart, lung, or brain disorders, and unstable vital signs. (2)For any mental illness, refer to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition for diagnostic exclusion. (3) Individuals with sleep disorders caused by central nervous system diseases or neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, and Lewy body dementia. (4) Suffering from other sleep disorders, such as sleep apnea syndrome, narcolepsy, periodic limb movements, restless legs syndrome, etc. (5)Women who are pregnant or breastfeeding. (6)Individuals with severe external injuries or those scheduled for surgery in the near future. (7)Individuals who cannot tolerate needle pricks, are prone to fainting during injections, or have allergies to needles. (8)Individuals with intellectual disabilities or incapacitated persons who are unable to cooperate with questionnaire completion or acupuncture treatment. (9)Individuals who refuse random assignment or are unwilling to adhere to the established study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index(PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAMD);Self-Rating Anxiety Scale (SAS);Self-Rating Depression Scale(SDS);Traditional Chinese Medicine Syndrome Score Scale for Insomnia; | — |
Countries
China
Contacts
Public ContactBing Yan
The fourth Clinical Medical College of Guangzhou University of Chinese Medicine
Outcome results
None listed