General Anxiety Disorder
Conditions
Interventions
High dose:Taken orally
Low dose: Taken orally
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Meet the DSM-V diagnostic criteria for generalized anxiety disorder prior to enrollment; 2. Conform to the traditional Chinese medicine syndrome differentiation of liver qi stagnation transforming into fire; 3. Age between 18 and 70 years old (inclusive of both limits), gender unrestricted; 4. HAMA score = 14 and = 29, with anxiety mood (item 1) scoring = 2 and depressive mood (item 6) scoring = 2; 5. The baseline HAMA score before enrollment shows a reduction rate of < 25% compared to the screening time.6. Voluntarily participating in this clinical trial, capable of cooperating with the researchers in conducting the trial, and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Concomitant psychiatric disorder with any of the following: delusional disorder, separation anxiety disorder, panic disorder, agoraphobia, anxiety disorder due to other somatic disorders, substance/medication-induced anxiety disorder, social anxiety disorder (social phobia), obsessive-compulsive disorder, post-traumatic stress disorder and adjustment disorder, depression, bipolar and psychotic disorder, anorexia nervosa; 2. Combination of any substance-related and addictive disorders, including alcohol, caffeine, marijuana, hallucinogens, inhalers, opioids, sedatives, hypnotic drugs, stimulants, tobacco, etc.; 3. Systemic psychotherapy has been received in the past or cannot be stopped during the trial; 4. Patients with severe or unstable heart, liver, kidney, endocrine, digestive, blood and other physical diseases; 5. Abnormal liver and kidney function: ALT or AST = 1.5 times the upper limit of normal, or SCr > upper limit of normal; 6. HAMD- 17 score=17 points; 7. Those who have suicidal tendencies as judged by the researcher; 8. Those who are unsupervised or unable to take medicine according to the doctor's instructions; 9. Known or suspected of having a history of allergy or serious adverse reactions to the test drug and its excipients, or allergic constitution; 10. Pregnant, lactating women or those who have recently planned to give birth; 11. Those who have participated in other drug clinical trials within 3 months before screening; 12. Other conditions that the investigator deems inappropriate to participate in this experiment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| CGI-Clinical Global Impression Scale;Quality of life scale;TCM Syndrome Points;Pittsburgh Sleep Index Scale; | — |
Countries
China
Contacts
Public ContactRui Gao
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed