Depression with kidney deficiency and liver depression
Conditions
Interventions
High dose group:3 bags of Yi'nao Jieyu Granules, 2 times a day, take it with warm water in the morning and after dinner. One fluoxetine hydrochloride capsule simulation capsule, once a day, orally in
Low dose group:2 bags of Yi'nao Jieyu Granules + 1 bag of Yi'nao Jieyu Granules Simulator, twice a day, take it with warm water in the morning and after dinner. One fluoxetine hydrochloride capsule si
Placebo group:3 bags of Yi'nao Jieyu Granule Simulator, twice a day, take it with warm water in the morning and after dinner. One fluoxetine hydrochloride capsule simulation capsule, once a day, orall
Positive drug group:3 bags of Yi'nao Jieyu Granule Simulator, twice a day, take it with warm water in the morning and after dinner. 1 fluoxetine hydrochloride capsule, once a day, orally in the mornin
Sponsors
Beijing Anding Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Outpatients aged 18 (inclusive) to 65 (inclusive) years, no gender limit; 2. Conform to the diagnosis of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5); 3. In line with TCM syndrome differentiation, it is depression of kidney deficiency and liver stagnation type; 4. HAMD17 score of 18 points = 2 points; 5. Baseline HAMA total score = 2 points; 6. Understand the test steps and content, and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Have a history of suicide attempt, or currently have a high risk of suicide, or item 3 (suicide score) of the HAMD17 depression scale >= 3; 2. Depressive episodes secondary to organic mental disorders caused by a systemic disease or a neurological disease, such as depression caused by hypothyroidism; 3. Compared with the screening/washing period, the HAMD17 total score in the baseline period has a score reduction rate of > 25%; 4. Refractory depression (previous or current application of 2 or more antidepressants with different chemical structures, after a sufficient dose and a full course of treatment (for example, the maximum dose of treatment according to the instructions for at least 4 weeks) is ineffective or has little effect) ; 5. Associated with severe or unstable cardiovascular, respiratory, liver, kidney, endocrine, blood (if bleeding tendency) system or other system diseases; 6. There is a history of convulsions in the current or past history; or the investigator judges that there is a disease that may increase the risk of convulsions; or the patient is currently receiving drugs or other treatments that will lower the threshold for convulsions; history of single-onset febrile seizures in childhood is not included; 7. The patient has a history of neurospinal demyelination or family history; 8. Alcohol and drug dependence within 1 year before screening; 9. Can not swallow oral drugs, or have a history of gastric or intestinal surgery and any other conditions that may interfere with drug absorption, distribution, metabolism or excretion; 10. During the screening or baseline period, if the investigators believe that the patient's physical examination and laboratory examination are abnormal and judged to have obvious clinical significance, the following indicators exceed the following standards: ALT or AST index is higher than 2 times the upper limit of normal; Cr is higher than the upper limit of normal; two or more of the five thyroid function indicators are higher than 1.2 times the upper limit of normal or 0.8 times lower than the lower limit of normal, or the investigator believes that there is hypothyroidism or hyperthyroidism; 11. The electrocardiogram (ECG) during the screening period is abnormal and has obvious clinical significance, such as the QTc interval of males >=450ms, the QTc interval of females >=470ms, or the situation that the investigator considers unsuitable for selection; 12. Regularly took antidepressants within 2 weeks before screening, and discontinued psychotropic drugs for less than 7 half-lives before randomization (monoamine oxidase inhibitors for at least 2 weeks, fluoxetine for at least 1 month); 13. Received systemic modified electroconvulsive therapy (MECT) or transcranial magnetic stimulation (TMS) therapy, vagus nerve stimulation (VNS) therapy, and systemic psychotherapy 3 months before screening; received systemic light therapy, laser therapy, psychiatric-related acupuncture, systemic biofeedback therapy or other physical therapy related to mental illness within 2 weeks prior to screening; underwent psychiatric surgery; 14. Patients who are pregnant, breastfeeding, or women of childbearing age have positive blood HCG/urine pregnancy test results during the screening period; or males or females of reproductive potential with reproductive potential during the trial cannot take effective contraceptive measures; or plan to conceive (give) within 3 months after the trial begins; 15.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Eisenberg Depression Scale;Hamilton Depression Rating Scale;Endpoint response rate;Remission rate of treatment endpoint;TCM syndrome score;Therapeutic effects of TCM syndromes;Hamilton Anxiety Scale;Clinical global impression scale;Short Form of Quality of Life Measurement Scale; | — |
Countries
China
Contacts
Public ContactZhang Ling
Beijing Anding Hospital Affiliated to Capital Medical University
Outcome results
None listed