Generalized Anxiety Disorder
Conditions
Interventions
Experimental Group:Standard dosage of Xiegan Qingxin Decoction granules.
Control Group:Low-dose Xiegan Qingxin Decoction granules (Chinese herbal ingredients content at 10% of the experimental group)
Sponsors
Xiyuan Hospital of CACMS
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for generalized anxiety disorder according to DSM-5 (Western medicine); (2) Meets the diagnostic criteria for liver meridian with hyperactive fire syndrome (Traditional Chinese Medicine); (3) Aged 18 to 70 years old (inclusive), with no restriction on gender; (4) HAMA score is between 14 and 29, with a score of at least 2 on item 1 (anxious mood); (5) Voluntarily participates in this clinical trial, can cooperate with the researchers, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Participants diagnosed with mental disorders other than GAD within the past 6 months, meeting DSM-5 criteria, including but not limited to: separation anxiety disorder, selective mutism, specific phobias, social anxiety disorder (social phobia), panic disorder, agoraphobia, anxiety disorders due to substances/medications, anxiety disorders due to other medical conditions, depressive disorders, obsessive-compulsive disorder, bipolar and psychotic disorders, neurodevelopmental and neurocognitive disorders, anorexia nervosa, etc.; (2) Participants with any substance-related and addictive disorders, including alcohol, cannabis, hallucinogens, inhalants, opioids, sedatives, hypnotics, stimulants, etc.; (3) Participants with a history of substance abuse; (4) Participants with HAMD scores =17 or HAMA item 6 (depressed mood) score >2; (5) Participants whose baseline HAMA score at enrollment compared to screening shows a reduction rate of =25%; (6) Participants with HAMD suicide score =3; (7) Participants with confirmed history of neurological diseases (e.g., cerebrovascular diseases, intracranial space-occupying lesions, etc.); (8) Participants with severe primary diseases of the liver, kidneys, hematopoietic system, endocrine system, or malignant tumors, or with ALT, AST >2.0 ULN, Scr >1.0 ULN; (9) Participants with contraindications to the medications in the emergency plan (e.g., zopiclone tablets, tartaric acid zolpidem tablets, eszopiclone tablets, lorazepam tablets) (e.g., myasthenia gravis, severe respiratory insufficiency, severe acute or chronic liver failure, severe sleep apnea syndrome, acute angle-closure glaucoma, etc.); (10) Participants with a history of allergy to the study drug or its excipients, or to drugs with similar chemical structures, or participants with allergic constitutions (e.g., allergies to two or more drugs or foods); (11) Women of childbearing potential who are pregnant, breastfeeding, planning pregnancy within 6 months, have positive pregnancy tests (urine HCG or blood HCG), or cannot take effective contraceptive measures during the trial; (12) Participants who have participated in other drug clinical trials or are currently participating in other clinical trials within 3 months prior to this trial; (13) Participants deemed unsuitable for clinical trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Score;Clinical Global Impressions–Severity Scale Score;Clinical Global Impression-Improvement Scale Score;Quality of Life (QOL) Score;TCM syndrome score;Sleep medications, types of anxiety medications, frequency of medication intake, dosage of medication; | — |
Countries
China
Contacts
Public ContactGao Rui
Xiyuan Hospital of CACMS
Outcome results
None listed