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Based on the correlation between intestinal immunity and brain inflammation to explore the pathological mechanism of depression and the study of Shouhuitongbian capsule to improve depression

Based on the correlation between intestinal immunity and brain inflammation to explore the pathological mechanism of depression and the study of Shouhuitongbian capsule to improve depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000352
Enrollment
Unknown
Registered
2025-02-19
Start date
2025-03-10
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Depressive disorder

Interventions

Non-Chinese medicine intervention group:Shouhui Tongbian capsule was not given
Healthy Control:None
Chinese medicine intervention group:Shouhui Tongbian capsule was given for treatment

Sponsors

Shandong Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: i. Depressive disorder group: Inclusion criteria: (I) Aged 18-65 years; Han male and female right-handed. (II) Meet the diagnostic criteria for depression in the 10th edition of the International Classification of Diseases (ICD). (III) Baseline Hamilton Depression Scale [17 items] score > 17. (IV) No systematic antidepressant therapy was used in the first 2 weeks of enrollment and no MECT was used in the last 3 months. ii. Normal control group: Entry criteria: (I) Aged 18-65 years; Han male and female right-handed. (II) No significant physical illness and no current or previous history of mental illness.

Exclusion criteria

Exclusion criteria: i. Depressive disorder group: Exclusion criteria: (I) depression secondary to organic disease or other mental disorders. (II) there is a serious violent attack or suicide and other unable to cooperate. (III) mental retardation dementia epilepsy and end-stage diseases. (IV) Patients with metal in the body and other conditions that cannot be scanned by MRI. (V) alcoholism or substance dependence. (VI) Obvious changes in eating habits in the past six months. (VII) Use of antibiotics corticosteroids cytokines high-dose probiotics or biological agents in the past six months; (VIII) Combined with chronic physical diseases such as cancer diabetes autoimmune diseases inflammatory bowel diseases etc.; (IX) Chronic disease that may affect the stability of the gut microbiome in the last 3 months such as high blood pressure diabetes immune deficiency autoimmune disease cancer inflammatory bowel disease diarrhea. (X) Gastrointestinal surgery gastroscopy colonoscopy or gastrointestinal barium meal in the past 5 years. ii.

Design outcomes

Primary

MeasureTime frame
Change in Hamilton Depression Rating Scale score;

Secondary

MeasureTime frame
Changes of intestinal flora indexes;Changes of blood inflammatory factor indexes;Alterations in Magnetic Resonance Indices;

Countries

China

Contacts

Public ContactTiangui Yu

Shandong Mental Health Center

sdyutg@163.com+86 531 8633 6798

Outcome results

None listed

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