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A prospective, randomized controlled clinical trial of Fuzheng Jiedu Formula in the treatment of pulmonary sepsis

A prospective, randomized controlled clinical trial of Fuzheng Jiedu Formula in the treatment of pulmonary sepsis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001742
Enrollment
Unknown
Registered
2025-09-15
Start date
2023-12-31
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Pulmonary sepsis

Interventions

Control group:Corresponding diagnosis and treatment should be carried out in accordance with the "Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Chinese Adults" and the
During the treatment period, both groups are strictly prohibited from using Chinese patent medicine injections such as Shenfu Injection, Shengmai Injection and Xuebijing Injection, as well as other Ch
Fuzheng Jiedu group:Conventional diagnosis and treatment combined with the Fuzheng Jidetoxification Formula (10g of aconite tablets, 15g of dried ginger, 20g of honey-fried licorice, 15g of honeysuck

Sponsors

University Town Hospital of Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) At the time of screening, the age should be =18 years old and =80 years old, with no gender restrictions. 2) Patients diagnosed with sepsis and intubated with tracheal intubation, and the infection focus is only from the lungs; Or diagnose severe pneumonia And patients with sepsis and tracheal intubation; 3) Be willing to participate in this study and have the informed consent form signed by the subject or their legal representative.

Exclusion criteria

Exclusion criteria: 1) Patients whose death is inevitable or highly likely to occur within 24 hours and those in hospice care; Patients after CPR Patients with advanced malignant tumors; Patients with severe blood diseases, immune-related diseases, etc. Known immunodeficient patients. Those who have received organ or bone marrow transplants, have HIV infection, or have taken immunosuppressants in the past three months; 2) Patients with non-pulmonary sepsis such as urogenic, enterogenic and bloodstream infections; 3) There is a history of severe allergic or non-allergic drug reactions, or allergies to two or more drugs, or it is known.Those who may be allergic to or have serious adverse reactions to the investigational drugs; 4) Patients who have participated in other clinical trials within the past three months; 5) Patients with severe mental disorders, pregnant and lactating women; 6) Other matters that the researcher deems unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
10-day and 28-day mortality rate;

Secondary

MeasureTime frame
Severity prediction and therapeutic effect evaluation Index (SOFA score), Systemic inflammatory Response Syndrome score (SIRS score), Clinical pulmonary Infection score (CPIS score), Murray lung injury score, number of organ dysfunction);Clinical treatment effective rate;Inflammatory indicators;T lymphocyte subsets;Mechanical assistance time;Hospital stay and total cost;TCM syndrome scoring;The rehospitalization rate and mortality rate within one year of follow-up;Clinical biochemical detection indicators: procalcitonin, lactic acid, blood gas analysis;Dosage and timing of vasoactive drugs;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactYe Ye

Emergency Department, University Town, Guangdong Provincial Hospital of Traditional Chinese Medicine

1004548400@qq.com+86 138 2977 1866

Outcome results

None listed

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