Generalized Anxiety Disorder
Conditions
Interventions
Escitalopram Oxalate:Escitalopram Oxalate Tablets (10-20 mg/day, taken orally 30 minutes after breakfast).Concomitant administration of a TCM granule placebo identical in appearance and taste to the i
Wumei Jieyu Decoction:Wumei Jieyu Decoction granules (one dose per day, divided into two servings taken 30 minutes after breakfast and dinner). Concomitant administration of a tablet placebo identical
TCM Granule Placebo:TCM granule placebo (composition: 95% dextrin + 5% Wumei Jieyu Decoction granules for flavor simulation). One dose per day, divided into two servings taken 30 minutes after breakf
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age & Type: Outpatients, male or female, aged between 18 and 70 years (inclusive). 2. Western Medicine Diagnosis: Meet the diagnostic criteria for Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 3. Traditional Chinese Medicine Diagnosis: TCM pattern diagnosis of depression disease (Yu Bing) with Cold-Heat Complex pattern. 4. Severity of Illness: Clinical Global Impression-Severity score = 4. Hamilton Anxiety Rating Scale total score = 14. Item 1 (depressed mood) of the Hamilton Depression Rating Scale-17 < 2. Generalized Anxiety Disorder-7 total score = 10. 5. Functional Impairment: Sheehan Disability Scale total score = 12. 6. General Condition: Stable vital signs, clear consciousness, and good communication skills to understand and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Comorbidities: Presence of other psychiatric disorders, impaired consciousness, or severe physical illnesses (as determined by the investigator to potentially interfere with efficacy and safety assessments). 2. Substance Abuse: History of abuse or dependence on any psychoactive substance (including alcohol) within the past 6 months. 3. Recent Medication: Use of benzodiazepines or related anxiolytics within 14 days prior to enrollment. 4. Treatment-Resistant History: Failure to respond to an adequate trial (at least 4 weeks) of two or more antidepressants and/or anxiolytics. 5. Allergy: Known history of allergy to any drug used in this study (escitalopram oxalate, Wumei Jieyu Decoction, or its placebo components). 6. Concurrent Therapy: Concurrent participation in structured, systematic psychotherapy. 7. Special Physiological Status: Women who are pregnant, planning pregnancy, or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Score of the Generalized Anxiety Disorder-7 Item Scale;Score on the Clinical Global Impression-Severity Scale; | — |
Countries
China
Contacts
Public ContactHongyan Li
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed