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

Stroke Clinical Trial

— TFXSHF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275219
• Other study ID #: 001/20180101
• Status: Recruiting
• Phase: Phase 4
• Start date: March 15, 2019
• Est. completion date: December 2021

Study information

• Verified date: May 2020
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Jianwen Guo, doctor
• Phone: 0086-13724899379
• Email: jianwen_guo[@]msn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complication
• Pneumonia
• Stroke

Intervention

Drug:
• Tongfu capsules
Tongfu capsules include 5 herbals
• The Placebo of Tongfu capsules
The Placebo of Tongfu capsules are made from dextrin, starch and so on.

Locations

Country	Name	City	State
China	Guangdong Province Hospital of Tradtional Chinese Medicine	Guangzhou	Guangdong

Sponsors (6)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine	Guangdong Provincial Hospital of Traditional Chinese Medicine, People's Hospital of Ganzhou City, People's Hospital of Lianjiang City, Shenyang No. 2 Hospital of Traditional Chinese Medicine, Yangjiang Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the all-cause mortality rate	Any cause of death	90±7 days
Primary	the mortality of stroke associated pneumonia	the death of stroke associated pneumonia	90±7 days
Secondary	changes in the gut microbiota between the experiment group and the control group	gut microbiota is monitored via 16S rRNA gene sequence analysis	Baseline (before drug), after drug 10-12 days
Secondary	National Institute of Health of stroke scale (NIHSS)	The NIHSS is for evaluation of neurological deficits. The NIHSS includes the following domains: level of conscious-ness, eye movements, integrity of visual fields, facial movements,arm and leg muscle strength, sensation, coordination, language,speech and neglect. Each impairment is scored on an ordinal scaleranging from 0 to 2, 0 to 3, or 0 to 4. The scoing of it ranges from 0 to 42. The higher scoring represents the more serious nerve defects. The scoring from 0-1 are normal or close to normal, 2-4 are mild, 5-15 are moderate, 6-20 are medium and severe and more than 20 points are severe neurological dysfunction.	Baseline (before drug), after drug 10-12 days, 90±7 days
Secondary	Stroke Specific Quality Of Life scale (SS-QOL) (SS-QOL) score	The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke.It consists of 49 items in the 12 domains of energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity (UE) function, vision, and work/productivity.; The score ranges from 0 to 100. The higher the score, the better the quality of life.	90±7 days
Secondary	Barthel index	The score ranges from 0 to 100. It represents the self-care ability. BI index =40 defines heavily dependent, ranges from 41 to 60 defines moderate dependent, ranges from 61 to 99 defines mild dependent and 100 defines independent. The scoring =<90 defines life cannot be independent. The percentage of BI 100-90 points in the three groups was statistically followed up by 90ds. The higher scoring represents a better outcome. There are 4 evaluation grades for 10 aspects(complete independence,part of the help, great help, absolutely dependent).The 10 aspects of the BI index includes eating(10,5,0,0), washing(5,0,0,0), making up(5,0,0,0), dressing up(10,5,0,0),control of the stool(10,5,0,0), control of the urination(10,5,0,0), going to toilet(10,5,0,0), bed-chair transform(15,10,5,0), walking on the ground(15,10,5), going up and down the stairs(10,5,0,0).	Baseline (before drug), after drug 10-12 days, 90±7 days
Secondary	Modified rankin scale (mRS)	It represents the recovery of neural functions. The scoring ranges from 0 to 5. Scoring 2-5 is defined as disability, which can be divided into 4 grades: mild, moderate, severe and severe.	after drug 10-12 days, 90±7 days