Mild and moderate generalized anxiety disorder (phlegm-heat disturbance syndrome)
Conditions
Interventions
Experimental group:Take both Wendan Tablet and Paroxetine Hydrochloride Tablet simulator
placebo-control group:Take both Wendan Tablet simulator and Paroxetine Hydrochloride Tablet simulator
positive-control group:Take both Wendan Tablet simulator and Paroxetine Hydrochloride Tablet
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who met DSM-V diagnostic criteria for generalized anxiety disorder before enrollment; 2. According to the syndrome differentiation of phlegm heat syndrome; 3. The patients with age >= 18 years old and = 14 and = 2 and depression mood (item 6) score <= 2; 5. Compared with the baseline HAMA score before screening, the score reduction rate was less than 25%; 6. The patients who voluntarily participate in this clinical trial can cooperate with the researchers to carry out the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with any of the following mental disorders: delusional disorder, separation anxiety disorder, panic disorder, agoraphobia, anxiety disorder due to other physical diseases, substance / drug anxiety disorder, social anxiety disorder (social phobia), obsessive-compulsive disorder, post-traumatic stress disorder and adaptation disorder, depression, bipolar and psychotic disorder, and anorexia nervosa Food; 2. Patients with any substance related or addictive disorder, including alcohol, caffeine, marijuana, hallucinogens, inhalants, opioids, sedatives, hypnotics, stimulants, tobacco, etc.; 3. The patients with positive urine test of drug abuse were screened; 4. The patients who received paroxetine in the first 4 weeks were screened; 5. Patients who received the following drugs within 4 weeks before screening or could not be stopped during the trial: (1) 5-HT and NE reuptake inhibitors (such as venlafaxine, duloxetine, etc.); (2) 5-HT1A receptor agonists (such as buspirone, tandospirone, etc.); (3) Selective 5-HT reuptake inhibitors (such as citalopram, escitalopram, sertraline, fluvoxamine, etc.); (4) Benzodiazepines (such as diazepam, alprazolam, clonazepam, lorazepam, etc.); (5) 5-HT receptor antagonist and reuptake inhibitor (such as trazodone); (6) Tricyclic and heterocyclic drugs (such as doxepin, amoxapine, maprotiline, etc.); (7) Antipsychotics (such as perphenazine, sulpiride, risperidone, quetiapine, olanzapine, etc.); (8) Deanxit. 6. Patients who had received or could not stop systematic psychotherapy in the past; 7. The subjects with HAMD-17 score >= 17; 8. The subjects judged by researchers to have suicidal tendency; 9. Patients with neurological diseases (such as cerebrovascular diseases, intracranial space occupying lesions, etc.) who have been known or confirmed by brain CT; 10. Patients with other serious diseases or malignant tumors of the system; 11. Patients with abnormal liver and kidney function: ALT or AST >= 1.5 times of the upper normal limit, or SCR > the upper normal limit; 12. Patients with known or suspected allergic history or serious adverse reactions to the test drug and its excipients, or allergic constitution; 13. Pregnant, lactating women or objects with family planning in the near future; 14. The subjects who participated in other drug clinical trials in the first 3 months were screened; 15. The researcher thinks that it is not suitable to participate in other situations of this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decrease of HAMA score at the time of the 12th weekend-visit of treatment compared with the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The decrease of HAMA score at the time of the 4th and 8th weekend-visit of treatment and the 4th and 8th weekend-visit of follow-up compared with the baseline;The percentage of subjects whose HAMA score decreased by more than 50% at the time of the 4th, 8th and 12th weekend-visit of treatment and at the 4th and 8th weekend-visit of follow-up compared with the baseline;The proportion of subjects with HAMA score <=7 at the time of the 4th, 8th and 12th weekend-visit of treatment and at the 4th and 8th weekend-visit of follow-up compared with the baseline;The decrease of HAMA mental anxiety factor score at the time of the 4th, 8th and 12th weekend-visit of treatment and the 4th and 8th weekend-visit of follow-up compared with the baseline;The decrease of QOL score at the time of the 4th, 8th and 12th weekend-visit of treatment and the 4th and 8th weekend-visit of follow-up compared with the baseline;The decrease of CGI-S score at the time of the 4th, 8th and 12th weekend-visit of treatment and the 4th and 8th weekend-visit of follow-up compared with the baseline;The decrease of CGI-I score at the time of the 4th, 8th and 12th weekend-visit of treatment and the 4th and 8th weekend-visit of follow-up compared with the baseline;The decrease of TCM syndrome score at the time of the 4th, 8th and 12th weekend-visit of treatment and the 4th and 8th weekend-visit of follow-up compared with the baseline;Recurrence during the 4th and 8th week of follow-up;Vital signs;Physical examination;Blood routine, urine routine and urine NAG enzyme, stool routine and occult blood, blood coagulation, blood biochemistry;Blood pregnancy test;12-lead electrocardiogram (ECG); | — |
Countries
China
Contacts
Public ContactYunling Zhang
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed