Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia (NCT04275219) | Clinical Trial Compass
UnknownPhase 4
Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia
China218 participantsStarted 2019-03-15
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. A diagnosis of intracerebral haemorrhage according to 2019 Chinese guidelines for the diagnosis and treatment of acute intracerebral haemorrhage \[9\], with a CT scan of the brain confirming acute intracerebral haemorrhage;
✓. Age between 18 and 85;
✓. A diagnosis of SAP according to the modified CDC standard \[10\];
✓. Within 7 days after stroke onset; and
✓. Willingness to participate and to sign the informed consent form.
Exclusion criteria
✕. Cerebral haemorrhage is confirmed by examination to be caused by a brain tumour, brain trauma, blood disease, cerebrovascular malformation (a congenital abnormality) or aneurysm;
✕. Cerebral herniation;
✕. A GCS score \<7;
✕. Any antibiotic treatment within 4 weeks before the start of the study;
✕
What they're measuring
1
the all-cause mortality rate
Timeframe: 90±7 days
2
the mortality of stroke associated pneumonia
Timeframe: 90±7 days
Trial details
NCT IDNCT04275219
SponsorGuangzhou University of Traditional Chinese Medicine
✕. Liver or kidney function parameters (such as alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[Cre\]) 3 times higher than the upper limit of normal;
✕. A clear history of gastrointestinal diseases, such as gastrointestinal tumours and inflammatory bowel disease, or a gastrointestinal bleeding period within 3 months;
✕. Immune-related diseases, such as SLE, rheumatoid arthritis, and Sjogren's syndrome, or receiving immunotherapy for other diseases; and