Randomized, double-blind, placebo-controlled, multicenter clinical study of Xiaoyao Mixture for the treatment of mild to moderate depressio
- Conditions
- Mild to moderate depressionMental and Behavioural Disorders
- Registration Number
- ISRCTN53183053
- Lead Sponsor
- Jinan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 108
1. Meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) with a HAMD-17 score between 7 and 24 points.
2. Meet the diagnosis criteria for liver depression and spleen deficiency syndrome;
3. Patients aged 16-65 years, regardless of gender;
4. Patients are voluntary, have informed consent, and have good compliance.
1. Patients with bipolar depression, refractory depression, or suicidal tendency (item 3 score of HAMD scale > 2 points);
2. Patients with other mental disorders such as organic mental disorders, schizophrenia, depression disorders caused by psychoactive substances and non-addictive substances;
3. Patients with severe organ lesions such as heart, liver and kidney, hematological diseases or tumors;
4. Patients who have received systematic treatment within 2 weeks before enrollment;
5. Pregnant or lactating women, or those who require fertility during the trial;
6. Patients who are participating in other clinical trials or have participated in other drug clinical trials within 3 months before screening;
7. Patients with a known or suspected allergy to the investigational drugs and excipients, or hypersensitivity constitution (defined as allergy to at least 2 drugs);
8. Patients who used fluoxetine within 4 weeks before enrollment;
9. Other situations that the researchers consider unsuitable for participating in this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method