drugset / Trial / NCT04275219
Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia
Phase 4
Unknown
218 enrolled
Guangzhou University of Traditional Chinese Medicine
Guangdong Provincial Hospital of Traditional Chinese Medicine · collabPeople's Hospital of Ganzhou City · collabPeople's Hospital of Lianjiang City · collabShenyang No. 2 Hospital of Traditional Chinese Medicine · collabYangjiang Hospital of Traditional Chinese Medicine · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Stroke-associated pneumonia (SAP) is the major complication of acute intracerebral haemorrhage (AICH), leads to poor clinical outcomes and increases the financial burden on the medical system. Prophylactic antibiotics do not reduce the mortality rate of SAP. The Tong-Fu-Xing-Shen herbal formula (TFXS) was shown to be effective for the prevention and treatment SAP in a previous clinical trial. To clarify whether TFXS is effective and safe for the treatment of SAP and affects the immunological mechanism of the "brain-gut-lung" pathway of SAP, the investigators designed this study.
Timeline
- Start
- 2019-03-15
- Primary completion
- 2021-12
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tongfu capsules | Traditional medicine (herbal / TCM) | 0.4 g | — |