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A Clinical Study on the Modulation of Sepsis-Induced Immunosuppression by Yiqi Huoxue Jiedu Formula Based on CD160-Mediated iNKT Cell Dysfunction

A Clinical Study Investigating the Regulation of Sepsis-Induced Immunosuppression by Yiqi Huoxue Jiedu Formula Based on CD160-Mediated iNKT Cell Dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000341
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-02-20
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Sepsis

Interventions

Control Group:The treatment adopted conventionaltherapy, following the 2016 Sepsis3.0 guidelines, the "2014 Chinese Guidelines for the Treatment of Severe Sepsis/Sepsis Shock," and the "2018 Chinese E
Experimental Group:In addition to the intervention, the Qi-invigorating, blood-activating, and detoxifying formula (Radix Ginseng 15g, Notoginseng 9g, Rheum palmatum 3g, decocted into a liquid, approx
course duration: 7 days) was also administered.

Sponsors

Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria of Sepsis 3.0 in 2016; 2. Meets the diagnostic criteria for the syndrome of acute deficiency in traditional Chinese medicine for sepsis as outlined in the 2014 "Chinese Guidelines for the Treatment of Severe Sepsis/Sepsis-Induced Shock"; 3. Suspected or confirmed sepsis for greater than or equal to 1 day, but less than or equal to 3 days; 4. Age =18 years and =85 years; 5. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Terminal state, individuals who may die within 24 hours; 2. Severe condition requiring cardiopulmonary resuscitation (CPR); 3. Advanced malignant tumors with cachexia; 4. Patients with autoimmune systemic diseases or immunodeficiency diseases (e.g., long-term use of hormones, immunosuppressive drugs, undergoing radiotherapy or chemotherapy, acquired immunodeficiency disease such as HIV infection, etc.); 5. Patients allergic to the Chinese herbal medicine in the Yiqi Huoxue Jiedu decoction prescription, or those with an allergic constitution; 6. Patients with concurrent pregnancy or currently breastfeeding; 7. Patients who have participated in other clinical trials within the past 3 months; 8. Patients with concurrent chronic liver disease or advanced liver cirrhosis; 9. Other situations deemed unsuitable for participation in the study by the clinical investigator.

Design outcomes

Primary

MeasureTime frame
Peripheral Blood iNKT Cell Count;Peripheral blood CD160/HVEM/BTLA expression profile;Peripheral Blood iNKT Cell Subtype Distribution;The expression levels of intracellular cytokines in peripheral blood iNKT cells.;Expression levels of key metabolic regulatory proteins in peripheral blood iNKT cells.;

Secondary

MeasureTime frame
7-day mortality rate;Blood Lactate;Serum Creatinine;Glutamic-oxaloacetic transaminase;Alanine transaminase;SOFA Score;APACHE II Score;28-Day Survival Status;ICU Length of Stay;Total hospitalization days;Blood Routine;Procalcitonin;T lymphocyte subsets;C-reactive protein;Interleukin-6;Tumor Necrosis Factor Alpha;

Countries

China

Contacts

Public ContactLi Jun

Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital

lijun1401@163.com13728065350

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026