Anxiety and depression state (liver qi stagnation syndrome)
Conditions
Interventions
Group 1:Shugan Granules
Group 2:Shugan Granule Simulator
Sponsors
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary signing of informed consent; 2. Western medicine diagnosis in accordance with anxiety and depression; 3. Conforms to the syndrome differentiation standard of liver qi stagnation syndrome; 4. At the time of enrollment, the Hamilton Anxiety Scale 7 points = HAMA total score = 14 points and/or the Hamilton Depression Scale 7 points <HAMD17 total score = 17 points; 5. Aged 18-65 years old.
Exclusion criteria
Exclusion criteria: 1. Excited withdrawal of drug overdose, hypnotic sedative drugs or anxiolytics, acute panic disorder, obsessive-compulsive disorder, phobia, suspected illness, mania or schizophrenia associated with anxiety; 2. Patients who have previously been diagnosed with anxiety or depression; 3. Patients with a history of suicide or a suicidal tendency or suicide score of =1 in HAMD17; 4. Organic mental disorders, psychoactive substances, non-addictive substances and depressed patients due to postpartum; 5. Anxiety and depression states of endocrine, cardiovascular and digestive system diseases such as hyperthyroidism, coronary heart disease, hypertension, irritable bowel syndrome; 6. Combine heart, brain, liver and kidney, hematopoietic, urogenital and other serious primary diseases and diabetes patients, including blood ALT, AST> normal upper limit of 2 times, serum creatinine (Cr)> normal upper limit; 7. Patients who have used antidepressant, anti-anxiety, antipsychotic western medicine and similar Chinese medicines within 4 weeks before enrollment; 8. Those who are allergic to or allergic to any component of the test drug (allergic to two or more foods or drugs); 9. Pregnancy or preparation for pregnancy and lactation women; 10. Patients who participated in or were participating in other clinical trials within one month prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale;Percentage of patients with a HAMA, HAMD17 score reduction rate = 50% after 4 and 8 weeks of treatment;Percentage of patients with HAMD17 score = 7 after 4 and 8 weeks of treatment;Percentage of patients with a total HAMA score of <7 after 4 and 8 weeks of treatment;Clinical Overall Impression Scale (CGI) score after 4 and 8 weeks of treatment;Changes in TCM syndrome scores after 4 and 8 weeks of treatment (total efficiency);After 4 and 8 weeks of treatment, the change of single symptom scores in TCM (disappearance rate);After 4 and 8 weeks of treatment, the difference in SAS scores from the anxiety self-rating scale was lower than the baseline.;After 4 and 8 weeks of treatment, the SDS score of the depression self-rating scale was lower than the baseline.; | — |
Countries
China
Contacts
Public ContactGuo Rongjuan
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Outcome results
None listed