Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia (TFXSHF)
Stroke, Complication
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke-associated pneumonia, Tong-Fu-Xing-Shen herbal formula, Traditional Chinese medicine, Brain-gut-lung axis, Randomized controlled trial
Eligibility Criteria
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.
Sites / Locations
- Guangdong Province Hospital of Tradtional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Tong-Fu-Xing-Shen herbal formula
The Placebo of Tong-Fu-Xing-Shen herbal formula
Tong-Fu-Xing-Shen herbal formula prescription (0.4g*36 capsules/bottle,1-4 capsules each time, three times a day.) for 10-12days.
The Placebo of Tong-Fu-Xing-Shen herbal formula prescription (0.4g*36 capsules/bottle,1-4 capsules each time, three times a day.) for 10-12 days.