Shenhuang granules for adults with sepsis
Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis: a Randomized, Double-blind, Placebo-controlled, Effective Clinical Trial
EARLY_PHASE1 · The First Affiliated Hospital of Zhejiang Chinese Medical University · NCT06514339
This trial will test whether Shenhuang granules can improve recovery and survival in adults with sepsis.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 410 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhejiang Chinese Medical University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06514339 on ClinicalTrials.gov |
What this trial studies
Hospitalized adults with sepsis will receive either Shenhuang granules or a matching placebo alongside standard care, with clinical staff collecting baseline and follow-up data. The primary outcome is 28-day mortality, and secondary outcomes include ICU/hospital length of stay, costs, ventilation-free days, TCM symptom scores, and organ function scores (SOFA, APACHE II). Blood tests will measure inflammatory markers, organ function, coagulation, and immune cell counts, and selected participants may provide samples for metabolomic analysis. Safety monitoring will record adverse events and allergic reactions throughout the study.
Who should consider this trial
Good fit: Adults (≥18) diagnosed with sepsis by Sepsis-3 criteria who can give informed consent and do not meet the exclusion criteria are ideal candidates.
Not a fit: Patients with very severe organ dysfunction (e.g., SOFA ≥15, expected death within 48 hours), significant liver or kidney failure, recent high-dose immunosuppression or chemotherapy, pregnancy, or contraindications to traditional Chinese medicine are unlikely to benefit.
Why it matters
Potential benefit: If effective, the treatment could reduce 28-day mortality and improve organ function and immune balance in patients with sepsis.
How similar studies have performed: There is limited clinical evidence specific to Shenhuang granules in sepsis; preclinical studies and small clinical reports suggest immune-modulating effects but no large randomized trials have yet shown clear mortality benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years old * Meet the diagnostic criteria of sepsis 3.0 guidelines * Sign informed consent. Exclusion Criteria: * Liver or kidney single SOFA score ≥3 points of liver and kidney dysfunction * Death is expected within 48 hours, or SOFA≥15 points, or APACHE II ≥30 points, or the patient refuses active treatment * Patients with allergic reactions to traditional Chinese medicine * Patients treated with chemotherapy or radiotherapy or high-dose immunosuppressants within the last 1 month * Participants in other clinical trials at the same time or within 30 days * Pregnant and lactating women * Patients with severe gastrointestinal bleeding, intestinal obstruction, or severe intraperitoneal pressure elevation (IAP≥20mmHg).
Where this trial is running
Hangzhou, Zhejiang
- First Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Wu JianNong, doctor
- Email: 13777571598@163.com
- Phone: 13777571598
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis, Shenhuang granules, Evidence-based evaluation, Effect mechanism research