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Jianpi Jieyu Decoction in patients with Major Depressive Disorder presenting spleen deficiency syndrome: A Randomized Controlled Trial

Study on the Mechanism of Traditional Chinese Medicine in Treating Depression Associated with Childhood Trauma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001537
Enrollment
Unknown
Registered
2026-06-20
Start date
2023-12-31
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Major Depressive Disorder

Interventions

JPJY group:JPJY plus low?dose SSRI(20 mg/d) for 8 weeks
Control group:placebo plus standard?dose SSRI (50 mg/d) for 8 weeks

Sponsors

Shanghai Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for a major depressive episode as defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V). (2) Meet the diagnostic criteria for depression with childhood trauma: Hamilton Depression Rating Scale-17 (HDRS-17) score = 17; have a history of childhood trauma and a Childhood Trauma Questionnaire (CTQ-SF) score above the cut-off value. (3) TCM syndrome differentiation: Liver depression and spleen deficiency syndrome: mental depression, chest and rib distension, excessive suspicion and worry, frequent sighing, poor appetite, weight loss, feeling tired after slight activity, fullness and belching in the epigastrium, loose or dry stools, or discomfort in the throat; thin white tongue coating, taut and thin or taut and slippery pulse. (5) No gender restrictions, age 18-60 years old; (6) No severe heart, liver, or kidney diseases, no organic brain diseases, no history of tumors, blood diseases, rheumatism, malnutrition, or neurodegenerative diseases; (7) No history of tobacco, alcohol, or other psychoactive substance abuse; (8) Provide informed consent.

Exclusion criteria

Exclusion criteria: (1) Have severe heart, liver or kidney diseases; have brain organic diseases; have severe cardiovascular diseases, tumors, blood diseases history, rheumatism, malnutrition and neurological degeneration and other diseases; depressive episodes secondary to other mental disorders or physical diseases; (2) Have a history of tobacco, alcohol and other psychoactive substance abuse; (3) Pregnant women;

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale,HAMD;

Secondary

MeasureTime frame
Chinese Medicine Symptom Scale;

Countries

China

Contacts

Public ContactLanying Liu

Shanghai Mental Health Center

balindaliu@163.com13516816012

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026