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| Name | Class |
|---|---|
| Heilongjiang Quanle Pharmaceutical Co., Ltd. | INDUSTRY |
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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:
Participants are required to complete the following procedures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator |
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| intervention group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Ciwujia Granules | Drug | Take Compound Ciwujia Granules or placebo twice daily for 8 weeks; Continue concomitant SSRI medication therapy throughout the treatment period; |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of the treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Schizophrenia spectrum/other psychotic disorders, Bipolar and related disorders, Anxiety disorders, OCD, or somatic symptom disorders, Substance-related/addictive disorders (excluding caffeine/nicotine), Positive urine drug screen at screening;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2025 | Jul 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2025 | Jun 26, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| placebo | Drug |
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| 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. | 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;
| 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. | 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). | From enrollment to the end of treatment at 8 weeks |