Status:
UNKNOWN
Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia
Lead Sponsor:
Guangzhou University of Traditional Chinese Medicine
Collaborating Sponsors:
People's Hospital of Ganzhou City
People's Hospital of Lianjiang City
Conditions:
Stroke
Complication
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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. Prophyl...
Detailed Description
This is a multicentre, randomized, double-blind, placebo-controlled clinical trial. A total of 218 patients will be recruited and randomly assigned to the experimental group (EG) or the control group ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- For inclusion, participants will need to fulfil all the following 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
- Participants with any of the following conditions will be excluded:
- 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;
- Pulmonary tuberculosis, pulmonary oedema, pulmonary embolism, noninfectious pulmonary oedema or respiratory circulation failure;
- 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
- Unsuitable for the trial as decided by the researchers.
Exclusion
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT04275219
Start Date
March 15 2019
End Date
December 1 2021
Last Update
September 7 2020
Active Locations (1)
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1
Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, China, 510120