Clinical trial NCT04275219: Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia
Official title: Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia (TFXSHF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stroke
Complication
Keywords: stroke-associated pneumonia
Tong-Fu-Xing-Shen herbal formula
Traditional Chinese medicine
Brain-gut-lung axis
Randomized controlled trial
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: People's Hospital of Ganzhou City
name: People's Hospital of Lianjiang City
name: Yangjiang Hospital of Traditional Chinese Medicine
name: Shenyang No. 2 Hospital of Traditional Chinese Medicine
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2020-02-19
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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 (CG) in a 1:1 ratio. The treatment course will be 10-12 consecutive days, with a 90±7-day follow-up. The primary outcome is the all-cause mortality rate and the mortality of pneumonia at the 90±7-day follow-up. Secondary outcomes include changes in the gut microbiota; changes in the NIHSS score, BI index, mRS score, and Stroke-Specific Quality of Life scale (SS-QOL) score; and so on.

Eligibility criteria: Inclusion criteria

For inclusion, participants will need to fulfil all the following criteria:

1. 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;
2. Age between 18 and 85;
3. A diagnosis of SAP according to the modified CDC standard \[10\];
4. Within 7 days after stroke onset; and
5. Willingness to participate and to sign the informed consent form.

Exclusion criteria

Participants with any of the following conditions will be excluded:

1. Cerebral haemorrhage is confirmed by examination to be caused by a brain tumour, brain trauma, blood disease, cerebrovascular malformation (a congenital abnormality) or aneurysm;
2. Cerebral herniation;
3. A GCS score \<7;
4. Any antibiotic treatment within 4 weeks before the start of the study;
5. Pulmonary tuberculosis, pulmonary oedema, pulmonary embolism, noninfectious pulmonary oedema or respiratory circulation failure;
6. 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;
7. A clear history of gastrointestinal diseases, such as gastrointestinal tumours and inflammatory bowel disease, or a gastrointestinal bleeding period within 3 months;
8. Immune-related diseases, such as SLE, rheumatoid arthritis, and Sjogren's syndrome, or receiving immunotherapy for other diseases; and
9. Unsuitable for the trial as decided by the researchers.

Primary outcomes:
measure: the all-cause mortality rate
timeFrame: 90±7 days
measure: the mortality of stroke associated pneumonia
timeFrame: 90±7 days
Secondary outcomes:
measure: changes in the gut microbiota between the experiment group and the control group
timeFrame: Baseline (before drug), after drug 10-12 days
measure: National Institute of Health of stroke scale （NIHSS）
timeFrame: Baseline (before drug), after drug 10-12 days, 90±7 days
measure: Stroke Specific Quality Of Life scale (SS-QOL) (SS-QOL) score
timeFrame: 90±7 days
measure: Barthel index
timeFrame: Baseline (before drug), after drug 10-12 days, 90±7 days
measure: Modified rankin scale (mRS)
timeFrame: after drug 10-12 days, 90±7 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Tradtional Chinese Medicine
state: Guangdong
Study officials:
References: