Insomnia
Conditions
Interventions
Treatment group:Take 4.8g of Jiao-tai-wan Granules (equivalent to 20g of Coptis chinensis and 2g of cinnamon in decoction pieces) into blank capsules. Divide the capsules filled with the medicine into
Placebo group:4.8g of placebo granules were respectively placed into exactly the same blank capsules. The capsules filled with the drugs were evenly divided into two portions. Participants who met the
Sponsors
The first Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria for insomnia (non-organic sleep disorder) as outlined in the Chinese Classification and Diagnostic Criteria of Mental Disorders, 3rd Edition (CCMD-3): 1. Insomnia is the predominant symptom, including difficulty falling asleep, shallow sleep, frequent dreams, early awakening, or difficulty returning to sleep after waking, with associated discomfort, fatigue, or daytime sleepiness; 2. A preoccupation with the consequences of insomnia is dominant; 3. Dissatisfaction with sleep quantity or quality causes significant distress or impairment in social functioning; 4. Symptoms occur at least 3 times per week and have persisted for at least 1 month; 5. Secondary insomnia due to physical illness or mental disorders is excluded. 2) TCM pattern differentiation must indicate heart–kidney disharmony (referring to the *Guiding Principles for Clinical Research of New Chinese Medicines in the Treatment of Insomnia* and the national TCM textbook *Internal Medicine of Traditional Chinese Medicine): - Restlessness and inability to sleep, difficulty falling asleep, palpitations with vivid dreams, dizziness and tinnitus, soreness and weakness in the lower back and knees, heat in the five centers (chest, palms, and soles), night sweats, dry throat, spermatorrhea, irregular menstruation, red tongue with little coating, and a thin and rapid pulse. 3) Aged 18 to 60 years old (including 18 and 60), with a junior high school education or above; 4) With a PSQI score greater than 7; 5) Those who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Insomnia caused by physical illness, changes in lifestyle or external environmental disturbances; 2) A history of affective mental disorders, anxiety disorders, depression, schizophrenia and other serious mental disorders; 3) Those with physical diseases that affect the central nervous system; 4) Patients with severe primary diseases such as heart, liver, kidney, blood pressure and hematopoietic system disorders, and those with abnormal liver and kidney function (ALT, AST, BUN exceeding the normal value by =20%, CRE value exceeding the normal range); 5) Those who have been taking benzodiazepine drugs regularly for the past month; 6) Those who have taken sleep treatment drugs within the past week; 7) Those who are allergic to the known components of the study drug or have an allergic constitution; 8) Alcoholics and/or those who abuse and are dependent on psychoactive drugs; 9) Pregnant or lactating women; 10) Those with implanted metal objects in the body, including steel plates, steel nails, pacemakers, cochlear implants, etc., which are contraindications for magnetic resonance imaging.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index,PSQI;Polysomnography,PSG; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1H-MRS & Quantitative susceptibility mapping, QSM;TCM Syndrome Score;T-SOD;GSH;4-HNE;MDA;SI;TIBC;SF;Total Iron Colorimetric;Serum metabolomics study; | — |
Countries
China
Contacts
Public ContactYuan Zhengzhong
The first Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed