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Efficacy evaluation of Shufeng Jiedu Capsule on Toxic-heat sepsis: a randomized placebo-controlled multi-center clinical trial

Efficacy evaluation of Shufeng Jiedu Capsule on Toxic-heat sepsis: a randomized controlled multi-center clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008639
Enrollment
Unknown
Registered
2016-06-13
Start date
2016-06-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

sepsis

Interventions

treatment group:Shufeng Jiedu Capsule
treatment group:placebo

Sponsors

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic standard of septic; 2. Meet the diagnostic standard of sepsis of traditional Chinese medicine toxic-heat or stasis syndrome; 3. Duration is less than 24 hours; 4. Between the age of 18 to 70 years.

Exclusion criteria

Exclusion criteria: 1. Patients with immunosuppressive state; 2. Patients with burns, small cell lung cancer,C cell carcinoma of the thyroid gland, rheumatoid disease and the first day after trauma; 3. Cannot determine viscera dysfunction in patients with chronic hepatic insufficiency, renal insufficiency and blood system diseases whether happened after the infection; 4. Meet the diagnostic standard of sepsis of traditional Chinese medicine deficiency syndrome; 5. Patients with psychosis, pregnant women and younger than 18; 6. Patients die or discharge within 24 hours after staying in ICU; 7. Patients with chronic cardiac shock, long-term organ perfusion abnormalities; 8. Patients with lower gastrointestinal bleeding and shock; 9. Coma patients, including critical, delirious; 10. Patients using Xuebijing injection, ulinastatin and other traditional Chinese medicine (TCM).

Design outcomes

Primary

MeasureTime frame
Sequential Organ Failure Assessment (SOFA);

Secondary

MeasureTime frame
APACHE II;The scores of traditional Chinese medical syndrome;blood routine;liver function;renal function;myocardial enzyme;PCT;CRP;D - D dimer;

Countries

China

Contacts

Public ContactFei Aihua

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

feiaihua@medmail.com.cn+86 13651629006

Outcome results

None listed

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