Generalized Anxiety Disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: (1) Meet diagnostic criteria for generalized anxiety disorder (GAD); (2) Conform to diagnostic standards for spleen deficiency with dampness-heat syndrome; (3) Aged between 18 and 65 years; (4) Stable vital signs; (5) Clear consciousness; age-appropriate appearance; intact orientation; coherent thought processes; absence of hallucinations; no delusional ideation; congruent affect; no significant memory impairment; preserved intellectual functioning; retained insight.
Exclusion criteria
Exclusion criteria: (1)Severe anxiety and/or severe depression: SAS score >69 SDS score >72; (2)Symptoms potentially caused by substance dependence or common medical conditions (e.g. alcohol dependence hyperthyroidism diabetes coronary artery syndrome pheochromocytoma); (3)Severe psychiatric disorders including manic episodes bipolar disorder organic psychosis schizophrenia schizoaffective disorder persistent delusional disorder (paranoid psychosis) epilepsy-induced mental disorders or intellectual disability with comorbid psychiatric disorders; (4)Meeting ICD-10 diagnostic criteria for major depressive disorder with clear suicidal tendencies or a history of suicide attempts; (5)Discontinuation of CNS depressants/stimulants within 1 month or discontinuation of antidepressants/anxiolytics within 1 month; (6)Pregnant or lactating women or individuals with plans to conceive during the trial period; (7)Participation in other clinical trials within the past 3 months; (8)Patients with known allergies to the investigational drug; (9)Individuals weighing less than 40 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-Rating Anxiety Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cornell Medical Index;Pittsburgh sleep quality index;Self-rating depression scale; | — |
Countries
China
Contacts
Guangdong Provincial Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine)