Insomnia
Conditions
Interventions
Sponsors
Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients should meet the following criteria to be enrolled in the study: (1)aged =18 and = 65 years old; both male and female (2) diagnosed with insomnia in accordance with the International Classification of Sleep Disorders- third edition (ICSD-3); (3) meet the TCM diagnostic criteria of insomnia (conform to the differentiation standard of liver fire invading stomach); (4) ISI score >7 points and < 22 points moderate insomnia; (5) the patient signed the informed consent and voluntarily participated in the study. Inclusion Criteria for fMRI (1) Patients meeting the criteria in 3.2.3.1. (2) Right-handed (3) No illnesses related to Central Nervous System (4) No MRI contraindications (eg metal implants claustrophobia etc.). (5) Have not taken sedative hypnosis drugs within 3 months before entering this study and cannot take similar drugs and health products during treatment and follow-up; (6) Voluntarily perform a total of 2 multifunctional MRI scans and sign the informed consent form. Inclusion criteria for healthy controls (1) Aged =18 and = 65 years old; (2) PSQI = 5 points; (3) Right-handed; (4) Havent worked night shift in 3 months; (5) Not suffering from any systemic illnesses or organic lesions of the brain; (6) Not addicted to smoking alcohol etc and not following any special sleep and dietary regime; (7) Those who do not have contraindications to magnetic resonance examination (such as metal implants claustrophobia etc.); (8) Voluntarily agrees to do fMRI once and sign the informed consent form.
Exclusion criteria
Exclusion criteria: The study will not include patients if: (1) With severe primary diseases in the cardiovascular system pulmonary system liver kidney and hematopoietic system; or systemic diseases such as pain fever cough surgery etc.; (2) With obvious headache migraine or history of head trauma or mental illness; (3) Insomnia caused by alcohol abuse and/or psychotropic substance abuse and dependence (including sleeping pills); (4) Other types of sleep disorders such as sleep apnea restless legs syndrome (PSG shows sleep apnea-hypopnea index = 10 events /hr or PSG shows sleep periodic limb movements >15 times/hr); sleep disorders of shift workers etc.; (5) Patient is pregnant or lactating or planning for pregnancy; (6) Patient has participated in another clinical trials in the last 3 months. (7) Patients with severe visual auditory or language impairments; (8) Afraid of needles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI);Beck Depression Inventory (BDI);Polysomnography (PSG) Test;fMRI;Sleep Diary;Gastrointestinal Symptom Rating Scale (GSRS);Beck Anxiety Inventory (BAI);TCM syndrome scale; | — |
Countries
China
Contacts
Public ContactChen Yunfei
Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed