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Effects of berberine hydrochloride on sepsis and sepsis-induced immunosuppression

Mechanism of berberine targeting CXCR4 to regulate JAK-STAT/NF-?B pathway-mediated immunosuppression by Tregs-mregDC in sepsis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110568
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Sepsis

Interventions

Healthy volunteer control:No intervention
Treatment control:Standard treatment for sepsis + Berberine hydrochloride tablets (0.2g/ time, 3 times / day, 5 days in total)

Sponsors

Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Confirmed sepsis receiving standard treatment; (2) Age =18 years old; (3) No participation in any interventional clinical studies within the past 3 months; (4) Patients or family members have received informed consent and signed a paper-based informed consent form. Sepsis diagnosis follows the 2016 Sepsis 3.0 criteria recommended by the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM): infection + SOFA score >= 2 points.

Exclusion criteria

Exclusion criteria: (1) Cardiogenic shock; (2) Pregnant or lactating women; (3) Severe hepatic or renal impairment, malignant tumors, psychiatric disorders, acute or chronic inflammatory diseases, or other serious organic dysfunction; (4) Organ transplantation, rheumatic or immune-mediated diseases, or long-term use of immunosuppressive agents.

Design outcomes

Primary

MeasureTime frame
Inflammatory factors level;Proportion of immunosuppressive cells;

Secondary

MeasureTime frame
Protein expression in immunosuppression pathways;

Countries

China

Contacts

Public ContactJinlan Jin

Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine

jinjinlan@163.com+86 198 0671 6969

Outcome results

None listed

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