Clinical study of Kaixin Changyu granule in the treatment of post-stroke depressio
- Conditions
- Post stroke depression
- Registration Number
- ITMCTR2100004842
- Lead Sponsor
- The First Affiliated Hospital of Dalian Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Refer to the Key Points for Diagnosis of Various Cerebrovascular Diseases revised by the Chinese Medical Association to be diagnosed with stroke;
2. According to the Chinese Classification and Diagnosis of Mental Disorders-Third Edition (CCMD-III), subjects diagnosed with secondary mild to moderate depression, Hamilton Depression Scale (HAMD-17) 17 items Score between 7 and 24 points;
3. The age of the subject is between 40 and 80 years old, regardless of gender;
4. Patients who were diagnosed with depression for the first time after stroke (diagnosed as PSD within 6 months after stroke);
5. No history of mental illness or family history of mental illness before stroke;
6. Normal consciousness can cooperate with various examinations, no aphasia or severe cognitive impairment, mental status examination (MMSE score)> 17 points;
7. Liver and kidney function tests are normal;
8. Be able to provide a voluntary signed informed consent form.
1. Participate in any other clinical trials or take hormones and psychotropic drugs within the last 1 month;
2. Unstable vital signs, poor control of underlying diseases, or serious systemic diseases such as heart disease or malignant tumors;
3. Allergic to the ingredients of Kaixin Changyu Granules;
4. Pregnant or lactating women;
5. Magnetic resonance contraindications.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Homocysteine;High sensitivity C-reactive protein;Related scales;FA value of DTI;
- Secondary Outcome Measures
Name Time Method Incidence of adverse reactions;