The purpose of this clinical trial is to evaluate the therapeutic efficacy and safety of Compound Ciwujia Granules in treating depression disorder (heart-spleen deficiency syndrome). The study primarily aims to address the following key questions: * Can Compound Ciwujia Granules effectively alleviate depressive symptoms in patients with heart-spleen deficiency syndrome? * What adverse reactions might participants experience while taking Compound Ciwujia Granules? Researchers will compare Compound Ciwujia Granules to a placebo (a look-alike substance that contains no drug) to see if Compound Ciwujia Granules works to treat depression disorder. Participants are required to complete the following procedures: 1. Take Compound Ciwujia Granules or placebo twice daily for 8 weeks; 2. Continue concomitant SSRIs throughout the treatment period; 3. Return to the hospital for scheduled assessments at Week 4 and Week 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Take Compound Ciwujia Granules or placebo twice daily for 8 weeks; Continue concomitant SSRI medication therapy throughout the treatment period;
1. Take placebo twice daily for 8 weeks; 2. Continue concomitant SSRI medication therapy throughout the treatment period;
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
The change rate of Hamilton Depression Rating Scale-17#HAMD-17# after treatmen
Reduction rate = (Baseline HAMD-17 score - Week 4 HAMD-17 score) / Baseline HAMD-17 score. A HAMD-17 response rate ≥50% is defined as an effective treatment
Time frame: From enrollment to the end of the treatment at 8 weeks
Hamilton Anxiety Rating Scale#HAMA
HAMA scale is used to assess the severity of anxiety symptoms in patients with neurotic disorders and other conditions. Previous studies have reported good reliability and validity for this scale. The scores from all 14 items are summed to give a total score, which indicates the overall severity of anxiety: \< 17: Mild severity; 18-24: Mild to moderate severity; 25-30: Moderate to severe severity.
Time frame: From enrollment to the end of treatment at 8 weeks
Pittsburgh sleep quality index#PSQI#
PSQI is used to assess sleep quality over the past month. It is suitable for evaluating sleep quality in patients with sleep disorders and mental disorders, as well as in the general population. The total score ranges from 0 to 21 points. A total score of \>7 is commonly used as the cutoff threshold for determining the presence of subjective sleep problems.
Time frame: From enrollment to the end of the treatment at 8 weeks
Treatment Emergent Symptom Scale#TESS#
Among comparable scales, it provides the most comprehensive item coverage-assessing both common adverse symptoms/signs and multiple laboratory findings. The Treatment Emergent Symptom Scale (TESS) requires clinicians to evaluate each symptom across three dimensions: Severity, Relationship to Intervention, and Action Taken. Severity is rated on a 0-4 scale: 0\. = Absence of the symptom; 1. = Occasional presence of the symptom; 2. = Mild severity, no impairment to routine functioning; 3. = Moderate severity, producing some impairment to routine functioning; 4. = Severe, causing significant impairment or disability to routine functioning.
Time frame: From enrollment to the end of treatment at 8 weeks
Clinical Global Impression-global improvement#CGI-GI#
The Clinical Global Impression (CGI) scale is a comprehensive global assessment instrument. Originally developed by the World Health Organization (WHO) for the International Pilot Study of Schizophrenia (IPSS), it is designed to evaluate clinical treatment outcomes.The Global Improvement (GI) component requires clinicians to assess the degree of improvement or worsening in the patient's condition relative to baseline status. This evaluation compares the patient's current clinical state with their baseline condition at study entry, utilizing an 8-point Likert scale ranging from 0 to 7 for scoring.
Time frame: From enrollment to the end of treatment at 8 weeks
Serum Inflammatory Factors
Serum inflammatory factors refer to cytokines, chemokines, acute-phase proteins, and other immune mediators present in bloodstream circulation that participate in systemic inflammatory responses. collection of 5 ml fasting venous blood to measure serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β), and tumor necrosis fac-tor-α (TNF-α) using enzyme-linked immunosorbent assay (ELISA).
Time frame: From enrollment to the end of treatment at 8 weeks
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