A prospective, single-center, randomized, open-label, parallel-controlled clinical study on the efficacy and safety of Shenfu Injection in the treatment of septic shock (Syndrome of Yang-Qi collapse)
Phase 4
- Conditions
- Septic shock
- Registration Number
- ITMCTR2200006718
- Lead Sponsor
- Dongfang Hospital Beijing University of Chinese medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
(1) Conforming to the diagnostic criteria of septic shock;
(2) Age >= 18 years;
(3) 4.5 mmol/L <= arterial blood lactic acid <= 7.0 mmol/L;
(4) Accord with the diagnostic criteria of yang qi collapse syndrome;
(5) GCS=15 points;
(6) Sign the informed consent form voluntarily.
Exclusion Criteria
(1) Poor prognosis (estimated survival time<24 hours);
(2) After cardiopulmonary resuscitation;
(3) Pregnant or lactating women;
(4) Participated in another clinical trial in the last three months;
(5) Blood purification is required during observation;
(6) People who are allergic to ginseng and aconite injection or contain red ginseng and aconite.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 28-day mortality;
- Secondary Outcome Measures
Name Time Method Cardiac function and renal function;mean arterial pressure;Mechanical ventilation time;Dose and time of noradrenaline;duration of in-hospital;Arterial blood lactate level;Clinical efficiency;EICU hospital stay;TCM symptom score;