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Dynamic multi-omics clinical mechanism of Ganmai Dazao decoction in the intervention of subthreshold depression based on the axis of "Gut microbiota-neuroimmunology-brain function"

Dynamic multi-omics clinical mechanism of Ganmai Dazao decoction in the intervention of subthreshold depression based on the axis of "Gut microbiota-neuroimmunology-brain function"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001137
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Subthreshold depression

Interventions

Ganmai Dazao decoction group:On the basis of health education, patients were administered Jiawei Ganmai Dazao Decoction.
Placebo group:On the basis of health education, placebo granules were administered.

Sponsors

Fujian University of Traditional Chinese Medicine, College of Rehabilitation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Age 18–60 years, gender unrestricted; 2) Score of 16–25 on the Center for Epidemiologic Studies Depression Scale (CES-D); 3) Right-handed; 4) Signed informed consent and voluntary participation.

Exclusion criteria

Exclusion criteria: 1) Meet the diagnostic criteria for mood disorders, bipolar depressive disorder, psychosis, etc., according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 2) Have a history of major depression, epilepsy or family history of epilepsy, neurodegenerative diseases, cerebrovascular diseases, neurological diseases, brain injury, etc.; 3) Have a history of using antipsychotic drugs or addictive disorders (e.g., drug abuse, alcoholism, etc.); 4) Have contraindications to magnetic resonance imaging (MRI) scanning, such as internal metal implants (e.g., cardiac pacemakers, cochlear implants, metal joints and other ferromagnetic foreign bodies), hyperthermia, pregnancy, claustrophobia, etc.; 5) Patients with severe sleep disorders or severe anxiety disorders: Insomnia Severity Index (ISI) score = 22, Hamilton Anxiety Rating Scale (HAMA) score = 29; 6) Participants currently enrolled in other clinical trials that may affect the evaluation of the present study results.

Design outcomes

Primary

MeasureTime frame
HamiltonDepressionScale,HAMD;

Secondary

MeasureTime frame
PatientHealthQuestionnaire, PHQ-9;Perceived Stress Scale, PSS;Chinese Affective Scale, CAS;Generalized Anxiety Disorder,GAD-7;12-items Short From Health Survey,SF-12;Brain structure and function;

Countries

China

Contacts

Public ContactJingsong Wu

Fujian University of Traditional Chinese Medicine, College of Rehabilitation

wjs@fjtcm.edu.cn13609501214

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026