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)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200006718

Enrollment

Unknown

Registered

2022-10-28

Start date

2022-11-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Septic shock

Interventions

control group:0.9% normal saline 200ml

experimental group:Shenfu Injection 100ml+0.9% normal saline 100ml

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
28-day mortality;	—

Secondary

Measure	Time frame
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;	—

Countries

China

Contacts

Public ContactPo Huang

huangpo1992@126.com18811412783

Outcome results

None listed

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