General Anxiety Disorder
Conditions
Interventions
High dose group:Zaoren Anshen Oral Solution oral 20 ml each time once in the morning and once in the evening (the evening is taken before going to bed and try to ensure that the time interval between
Low dose group:Zaoren Anshen Oral Solution and Zaoren Anshen Oral Solution simulator, oral, 20 ml (10 ml of Zaoren Anshen Oral Solution and 10 ml of Zaoren Anshen Oral Solution simulator), once in th
Extremely low dose group:Zaoren Anshen Oral Solution simulator, oral,once in the morning and once in the evening (which is taken before going to bed in the evening, try to ensure that the interval bet
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1)Meets the diagnostic criteria for generalized anxiety disorder in DSM-5; (2)Meets the diagnostic criteria of traditional Chinese medicine for liver blood deficiency deficiency heat and internal disturbance syndrome; (3)Age range from 18 to 70 years old (including endpoint values) male and female not limited; (4)14 points = Hamilton Anxiety Scale (HAMA) score<28 points anxiety state (item 1) score = 2 points insomnia (item 4) score = 2 points cardiovascular system symptoms (item 9) or autonomic nervous system symptoms (item 13) score = 2 points; (5)Understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1)Diagnosed within 6 months prior to screening with a psychiatric disorder other than GAD that meets DSM-5 criteria including but not limited to: separation anxiety disorder selective mutism specific phobia social anxiety disorder (social phobia) panic disorder agoraphobia substance/substance-induced anxiety disorders anxiety disorders due to other physical illnesses depressive disorders obsessive-compulsive disorders bipolar and psychotic disorders neurodevelopmental and neurocognitive disorders and anorexia nervosa; (2)Comorbidity with any substance-related and addictive disorder including alcohol marijuana hallucinogens inhalants opioids sedatives hypnotic drugs stimulants etc; (3)Individuals with a history of drug abuse; (4)During the trial period psychotropic and sleeping pills cannot be discontinued; (5)Previously received or unable to stop systemic psychotherapy during the trial period; (6)Hamilton Depression Rating Scale (HAMD) score>18 points or HAMA Depression Mood Scale (item 6) score>2 points; (7)The baseline HAMA score before enrollment was compared with that during screening and the score reduction rate was = 25%; (8)HAMD suicide score = 3 points; (9)Known past evidence of comorbidities of the nervous system (such as cerebrovascular disease intracranial space occupying lesions etc.); (10)Patients with liver kidney hematopoietic system endocrine system and other serious primary diseases and malignant tumors or ALT AST > 2.0 ULN Scr > 1.0 ULN; (11)Fasting blood glucose > 8mmol/L glycosylated hemoglobin =6.5%; (12)People who are known to have a history of allergies to drugs with similar composition and chemical structure of the investigational drug or mimicant (e.g. people who are allergic to more than two drugs or food); (13)Women of childbearing potential are pregnant lactating have a birth plan during the study period have a positive pregnancy test (urine HCG or blood HCG) or cannot take effective contraceptive measures during the trial; (14)Patients who have participated in or are currently participating in another drug clinical trial within 3 months prior to enrolling in this trial; (15)Participants considered inappropriate for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMA score subtraction from baseline (8 weeks); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with =50% reduction in HAMA score (2 weeks, 4 weeks, 6 weeks, 8 weeks);Type, frequency, and dosage of sleeping drugs and anti-anxiety drugs (2 weeks, 4 weeks, 6 weeks, 8 weeks);Insomnia Severity Index(ISI) scores (2 weeks, 4 weeks, 6 weeks, 8 weeks);HAMA score subtraction from baseline (2 weeks, 4 weeks, 6 weeks);Chinese medicine symptom score;Quality of Life Assessment Brief scores (QOL-BREF)(2 weeks, 4 weeks, 6 weeks, 8 weeks);HAMA factor scores (somatic anxiety, psychic anxiety) (2 weeks, 4 weeks, 6 weeks, 8 weeks);Proportion of subjects with HAMA scores =7 (2 weeks, 4 weeks, 6 weeks, 8 weeks);Clinical Global Impressions-Improvement(CGI-I) score reduction from baseline (2 weeks, 4 weeks, 6 weeks, 8 weeks);Clinical Global Impressions-Severity(CGI-S)score reduction from baseline (2 weeks, 4 weeks, 6 weeks, 8 weeks); | — |
Countries
China
Contacts
Public ContactGao Rui
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed