Insomnia
Conditions
Interventions
Acanthopanax Capsules Group:Acanthopanax Capsules
Sponsors
Hubei Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: All of the following criteria must be met for inclusion:?? (1) Aged between 18 and 75 years, male or female; (2) Meeting the diagnostic criteria for insomnia disorder; (3) Voluntarily participating and signing the ?informed consent form
Exclusion criteria
Exclusion criteria: Subjects must be excluded if meeting any of the following criteria:?? (1) History of allergy to any component of the investigational product; (2) Conditions judged by the investigator to affect drug absorption, distribution, or metabolism (e.g., prior liver, kidney, or gastrointestinal resection surgery); (3) Severe psychiatric disorders or emotional disturbances within the past year (e.g., anxiety, depression, suicidal ideation/attempts), or long-term use of CNS depressants/stimulants; (4) Hamilton Anxiety Rating Scale (HAMA) score =14 (indicating definite anxiety) or Hamilton Depression Rating Scale (HAMD) score =17 (indicating moderate depression) at screening; (5) Pregnant, lactating women, or women of childbearing potential unable to use effective contraception during the study; (6) Participation in other drug clinical trials within the past month; (7) Any other reason deemed by the investigator to contraindicate trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Degree of sleep quality improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance across Various Dimensions of Sleep Quality; ?Insomnia Severity;Changes in the Usage Rate and Dosage of Sedative-Hypnotic Drugs; | — |
Countries
China
Contacts
Public ContactChen Gang
Hubei University of Chinese Medicine
Outcome results
None listed