Insomnia
Conditions
Interventions
High-dose Jiao-tai-wan group:Encapsulate 4.8 g of Jiao-tai-wan granules (equivalent to 20 g of Coptidis Rhizoma and 2 g of Cinnamomi Cortex as decoction pieces) in identical empty capsules
divide the filled capsules into two equal portions. Eligible participants will take one portion orally at 16:00 and the other at 21:00 daily for 2 consecutive weeks.
Low-dose Jiao-tai-wan group:Thoroughly mix 2.4 g of Jiao-tai-wan granules (equivalent to 10 g Coptidis Rhizoma plus 1 g Cinnamomi Cortex) with 2.4 g of placebo granules, fill the blend into identical
Placebo group:Encapsulate 4.8 g of placebo granules in identical empty capsules
divide the filled capsules into two equal portions. Eligible participants will take one portion orally at 16:00 and the other at 21:00 daily for 2 consecutive weeks. Both Jiao-tai-wan and placebo are
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 18–60 (inclusive), with at least a junior high school education level; 4) PSQI score > 7; 5) Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1) Insomnia attributable to physical illness, lifestyle changes, or external environmental disturbances; 2) History of affective psychosis, anxiety disorders, depression, schizophrenia, or other severe mental disorders; 3) Concurrent physical diseases that affect the central nervous system; 4) Severe primary diseases of the heart, liver, kidneys, blood pressure, or hematopoietic system, or abnormal hepatic/renal function (ALT, AST, BUN = 20 % above the upper limit of normal, or creatinine outside the normal range); 5) Regular continuous use of benzodiazepines or related sedative-hypnotics within the past month; 6) Use of any sleep-promoting medication within the past week; 7) Known hypersensitivity to any study-drug ingredient or a history of allergic diathesis; 8) Alcohol abuse and/or use or dependence on psychoactive substances; 9) Pregnant or lactating women; 10) Presence of implanted metal objects (plates, screws, pacemakers, cochlear implants, etc.) that contraindicate MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index,PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Polysomnography,PSG;TCM syndrome points; | — |
Countries
China
Contacts
Public ContactYuan Zhengzhong
The first Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed