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Clinical efficacy evaluation of the fusu mixture(warming the kidney subsiding the yang and promoting diuresis) based on the theory of "cold transformation syndrome of Shaoyin"in the treatment of sepsis complicated with ARDS

Clinical efficacy evaluation of the fusu mixture(warming the kidney subsiding the yang and promoting diuresis) based on the theory of "cold transformation syndrome of Shaoyin"in the treatment of sepsis complicated with ARDS

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000471
Enrollment
Unknown
Registered
2024-09-24
Start date
2024-10-10
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

18/10000 18/10000 real-time translation of Sepsis combined with acute respiratory distress syndrome Sepsis combined with acute respiratory distress syndrome

Interventions

Experimental group:conventional Western Medicine therapy and fusu mixture
Control group:conventional Western Medicine therapy and placebo

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old; (2) Complies with the 2023 ARDS guidelines and the 2016 Sepsis3.0 diagnostic criteria; and complies with the "cold transformation syndrome of Shaoyin"; (3) Expected hospitalization time = 7 days; (4) Sign the informed consent form; Note: Only those who meet the above four criteria can be included.

Exclusion criteria

Exclusion criteria: (1) Those who may die within 24 hours; (2) Patients with severe illness requiring cardiopulmonary resuscitation; (3) Late stage malignant tumors with cachexia; (4) Individuals who are allergic to the the components of the fusu mixture or have an allergic constitution; (5) Pregnant women; (6) Participated in other clinical trials in the past 3 months; (7) Expected offline difficulties; (8) Clinical researchers believe that there are other circumstances that are not suitable for participation in the study. Note: Any of the above criteria must be excluded.

Design outcomes

Primary

MeasureTime frame
The number of days without mechanical ventilation in 28 day surviving patients;

Secondary

MeasureTime frame
Blood gas analysis;breathe;white blood cell;clinical pulmonary infection score;Procalcitonin;Heart rate;Chest CT;extravascular lung water index;CRP;ECG;Temperature;IL-6;ICU length of stay;TNF-a;t-lymphocyte subset;SOFA;Apache-II;28 day and 90 day all-cause mortality rates;Blood pressure;

Countries

China

Contacts

Public ContactXiujuan Zhou

Hospital of Chengdu University of Traditional Chinese Medicine

420255672@qq.com15002893316

Outcome results

None listed

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