Clinical Study of Compound Ciwujia Granules in the Treatment of Depression
NCT07085143 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-04-23
Summary
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.
Conditions
- Depression - Major Depressive Disorder
- Depression Disorders
Interventions
- DRUG
-
Compound Ciwujia Granules
Take Compound Ciwujia Granules or placebo twice daily for 8 weeks; Continue concomitant SSRI medication therapy throughout the treatment period;
- DRUG
-
1. Take placebo twice daily for 8 weeks; 2. Continue concomitant SSRI medication therapy throughout the treatment period;
Sponsors & Collaborators
-
Heilongjiang Quanle Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Shanghai Mental Health Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2026-06-20
- Completion
- 2026-07-30
Countries
- China
Study Locations
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