Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia (TFXSHF)

Guangzhou University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 4

Conditions: Complication; Stroke

Treatments: Drug: Tongfu capsules; Drug: The Placebo of Tongfu capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT04275219

001/20180101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 2 patient groups, including a placebo group

Tong-Fu-Xing-Shen herbal formula

Experimental group

Description:

Tong-Fu-Xing-Shen herbal formula prescription (0.4g\*36 capsules/bottle，1-4 capsules each time, three times a day.) for 10-12days.

Treatment:

Drug: Tongfu capsules

The Placebo of Tong-Fu-Xing-Shen herbal formula

Placebo Comparator group

Description:

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.

Treatment:

Drug: The Placebo of Tongfu capsules