Moderate Poststroke depression
Conditions
Interventions
Western medicine control group:Placebo granules+escitalopram
Chinese medicine treatment group:Xingshen Jieyu granules+escitalopram placebo
Integrated Chinese and Western Medicine Group:Xingshen Jieyu granules+escitalopram
Placebo group:Placebo granules+escitalopram placebo
Sponsors
Shanghai Seventh People's Hospital (the Seventh People's Hospital affiliated to Shanghai University of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who meet the diagnostic criteria for moderate depression in Western medicine and the diagnostic criteria for liver depression and spleen deficiency in traditional Chinese medicine are eligible for the study. The severity of depression is quantified using the Hamilton Depression Scale (HAMD-17), and patients with a score between 17 and 24 are eligible for inclusion in the moderate depression group. Patients must be between 18 and 75 years old, conscious and able to cooperate with various tests and examinations, with a Mini-Mental State Examination (MMSE) score of more than 17 for illiterates, more than 20 for those who completed primary education, and more than 24 for those who completed junior high school or above. Patients must also have a traditional Chinese medicine diagnosis of liver depression and spleen deficiency, have not taken other antipsychotic or antidepressant drugs for two weeks before enrollment, and voluntarily sign an informed consent form to participate in the study.
Exclusion criteria
Exclusion criteria: Patients with other psychiatric disorders, such as manic-depressive disorder or schizophrenia; those who were previously diagnosed with or had a significant history of depression before the stroke; those with a severe suicidal tendency (HAMD-17 suicide index score > 2 at baseline); those who are deaf, mute, aphasic, have consciousness disorders, significant intellectual disabilities or cannot cooperate with the examination due to other reasons; patients with cerebral hemorrhage, subarachnoid hemorrhage, and epilepsy; those with known alcohol or drug dependence; pregnant or lactating women; those who have participated in other clinical drug studies in the past month; and those who have had an allergy to the study drug in the past are excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton depression scale;TCM syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale;National Institutes of Health Stroke Scale;Barthel index score;Serum BDNF level;FMRI scan; | — |
Countries
China
Contacts
Public ContactHan Zhenxiang
Shanghai Seventh People's Hospital (the Seventh People's Hospital affiliated to Shanghai University of Traditional Chinese Medicine)
Outcome results
None listed