generalized anxiety disorder
Conditions
Interventions
Group 1:Alprazolam Tablets+Jiuwei Zhenxin Granules
Group 2:Jiuwei Zhenxin Granules
Sponsors
West China School of Medicine/West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient who signs the Informed Consent Form; 2. The patient who is an 18-70 years old male and female; 3. Standards of diagnosis in Western Medicine: Standard of diagnosis ICD-10 will be used, including the standards of F41.1 generalized anxiety disorder and F41.2 mixed anxiety and depression disorder: (1) Generalized anxiety disorder F41.1 generalized anxiety disorder refers to the condition in which a patient must have primary symptoms of anxiety during most of the time within at least several weeks, and these symptoms include: 1) Panic (being worry about the possible happiness in the future, feeling nervousness, difficult in attention and others); 2) Nervousness in sports (being restless, tension headache, tremor and unable to relax); 3) Hyperactivity of autonomic nerve (being unable to stand firm, sweat, tachycardia or shortness of breath, epigastric discomfort, dizziness, dry mouth and others). (2) Mixed anxiety and depression disorder: F41.2 mixed anxiety and depression disorder refers to the condition in which anxiety and depression disorder exist simultaneously but two set of symptoms cannot be met when considered during the corresponding diagnosis, which will be classified as mixed. Most of patients developing these relatively mild mixed symptoms will seek medical device in a primary health institution, while more patients are in the general population and the majority will not receive treatment in hospital or department of psychiatry through their lives, including anxiety and depression (mild and non-persistent); 4. HAMA Anxiety Scale score is = 14, in which the score of anxious state of mind (the first item) is = 2; 5. Standards of diagnosis in Traditional Chines Medicine: Industrial Standard For Traditional Chinese Medicine of The Peoples of Republic of China-Diagnostic Efficacy Standard of Chinese Medicine Syndrome issued by the State Administration of Technology Supervision in 1995; (1) Diagnostic standard of depression disease (ZY T001.1.94): The disease is caused by emotional upset and stagnation of Qi. The main symptoms are depression, emotionally restless, irritability and crying easily; The patient suffers from poor melancholy, dispiritedness, chest distress and abdominal distension, and frequent sigh, or symptoms such as loss of appetite, insomnia and dreamful sleep and irritability and crying easily; There is a history of anger-out expression, worry, sadness and other emotional injuries; Organic diseases can be excluded by examination of each system and laboratory tests; It should be distinguished from depressive psychosis and manic psychosis; (2) Standards of syndrome differentiation in Traditional Chinese Medicine: The syndrome of deficiency of both heart and spleen must has the main symptom (1) as well as one other symptom and three minor symptoms, and it can be diagnosed base on tongue and pulse; Syndrome of deficiency of both heart and spleen: main symptoms: thoughtfulness, worry and confusedness; insomnia and dreamful sleep; palpitation; Minor symptoms: Loss of appetite; physically and mentally fatigue; dizziness; sweat easily; frequent sigh; sallow complexion. Tongue and pulse: Pale tongue with thin and white coating; (2) Thin pulse string or deep thready pulse.
Exclusion criteria
Exclusion criteria: 1. The patient who suffers from serious cardiac, hepatic and renal diseases, or serious organic diseases; 2. A patient with other mental disorders accompanied by anxiety disorders, such as depression disorders, phobic anxiety disorders, panic disorders, obsessive-compulsive disorders, schizophrenia, and bipolar affective disorders; 3. A woman who is pregnant and breastfeeding or plans to be pregnant during the trial; 4. A patient with ALT greater than 1.5 times normal value; 5. A patient with the HAMD Depression Scale score = 17; 6. A patient with liver-yang hyperactivity (red tongue with yellow coating) from the perspective of Chinese medicine; 7. The subjects who participated in other clinical trial within 30 days;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMA total score;Factor scores of HAMA;Grading of efficacy of HAMA;Total score of TCM Syndromes;Grading of efficacy of TCM Syndromes; | — |
Countries
China
Contacts
Public ContactLi Jing
West China Hospital, Sichuan University
Outcome results
None listed