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Efficacy and safety of Chaihu Anxin Capsule in the treatment of mild to moderate depression: a multicenter, randomized, double-blind, placebo parallel-controlled clinical trial and mechanism of action

Efficacy and safety of Chaihu Anxin Capsule in the treatment of mild to moderate depression: a multicenter, randomized, double-blind, placebo parallel-controlled clinical trial and mechanism of action

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105404
Enrollment
Unknown
Registered
2025-07-02
Start date
2025-07-03
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate depression

Interventions

Experimental group:The daily oral dose of Chaihu Anxin Capsule is the recommended dose
Placebo control group:Patients were given placebo with Chaihu Anxin Capsule orally every day, and the dose was the same as that of the experimental group

Sponsors

The First Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Be between the ages of 18 and 65; 2.Confirmed diagnosis of mild to moderate depression (F32.0 or F32.1) according to the diagnostic criteria of the International Classification of Diseases and Classification of Diseases (ICD-10); HAMD-24 score between 8 and 35; 3.Patients with stable symptoms, who can understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Have a severe psychiatric illness (e.g., bipolar disorder, schizophrenia) or organic encephalopathy; 2.Patients with hypersensitivity to the study drug or its components; 3.Patients who are currently receiving other antidepressant therapy or participating in other clinical trials; 4.Pregnant or lactating women; 5.Patients with a suicide attempt or serious suicide risk.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale score;

Secondary

MeasureTime frame
Hamilton Anxiety Scale score;Liver function;Renal function;TCM Syndrome Assessment Scale score;

Countries

China

Contacts

Public ContactJing Yu

The First Hospital of Hebei Medical University

38565914@qq.com+86 311 8715 6675

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026