Based on the "Brain-gut -Lung" Axis the Mechanism of Treating Stroke-associated Pneumonia by Tong-Fu-Xing-Shen Capsules

  • STATUS
    Recruiting
  • participants needed
    378
  • sponsor
    Guangzhou University of Traditional Chinese Medicine
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Updated on 16 February 2024
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intracerebral hemorrhage
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Summary

The regulation of T cells / IL-17 pathway mediated by the intestinal flora has become a new molecular target for the treatment of SAP. To test whether TFXSCs are through the pathway as above, this protocol describes an ongoing randomized controlled clinical trial, based on the theory of traditional Chinese medicineTCM.

Description

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 378 patients will be recruited and randomly assigned to TFXSCs group or placebo-matched group in a 1:1 ratio. The treatment course is 10-12 consecutive days, with a 907-day follow-up.

Details
Condition Cerebrovascular accident, Complication
Age 18years - 85years
Treatment Tongfu capsules, The Placebo of Tongfu capsules
Clinical Study IdentifierNCT04275219
SponsorGuangzhou University of Traditional Chinese Medicine
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Diagnosis of spontaneous haemorrhage according to Western medicine, CT scan of brain confirmed acute intracerebral hemorrhage
Aged between 18 and 85
Diagnosis of modified CDC
within 7 days after stroke onset
Willingness to participate and to sign the informed consent form

Exclusion Criteria

Cerebral hemorrhage is confirmed by examination to be caused by a brain tumor, brain trauma, blood disease, cerebrovascular malformation (a congenital abnormality) or aneurysm
Patients with a cerebral hernia
GCS7
Received any antibiotic treatment within 4 weeks before the start of the study
Patients with pulmonary tuberculosis, pulmonary edema, pulmonary embolism, non-infectious pulmonary itomy and respiratory circulation failure
Patients with liver or kidney function (such as alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine[Cre]) 3 times higher than the normal upper limit
Patients with a clear history of gastrointestinal diseases such as gastrointestinal tumors, inflammatory bowel disease, a gastrointestinal bleeding period within 3 months
Patients with immune-related diseases such as SLE, rheumatoid arthritis, sjogren's syndrome or receiving immunotherapy for other diseases
Patients who are not suitable for the trial as decided by the researchers
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