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Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia (TFXSHF)
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.
Details
| Lead sponsor | Guangzhou University of Traditional Chinese Medicine |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 218 |
| Start date | 2019-03-15 |
| Completion | 2021-12 |
Conditions
- Stroke
- Complication
Interventions
- Tongfu capsules
- The Placebo of Tongfu capsules
Primary outcomes
- the all-cause mortality rate — 90±7 days
Any cause of death - the mortality of stroke associated pneumonia — 90±7 days
the death of stroke associated pneumonia
Countries
China