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

Primary Purpose

Stroke, Complication

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tongfu capsules
The Placebo of Tongfu capsules
Sponsored by
Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangdong Province Hospital of Tradtional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tong-Fu-Xing-Shen herbal formula

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

Arm 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.

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.

Outcomes

Primary Outcome Measures

the all-cause mortality rate
Any cause of death
the mortality of stroke associated pneumonia
the death of stroke associated pneumonia

Secondary Outcome Measures

changes in the gut microbiota between the experiment group and the control group
gut microbiota is monitored via 16S rRNA gene sequence analysis
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.
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.
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).
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.

Full Information

First Posted
February 11, 2020
Last Updated
September 4, 2020
Sponsor
Guangzhou University of Traditional Chinese Medicine
Collaborators
People's Hospital of Ganzhou City, People's Hospital of Lianjiang City, Yangjiang Hospital of Traditional Chinese Medicine, Shenyang No. 2 Hospital of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04275219
Brief Title
Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia
Acronym
TFXSHF
Official Title
Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia (TFXSHF)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine
Collaborators
People's Hospital of Ganzhou City, People's Hospital of Lianjiang City, Yangjiang Hospital of Traditional Chinese Medicine, Shenyang No. 2 Hospital of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Complication
Keywords
stroke-associated pneumonia, Tong-Fu-Xing-Shen herbal formula, Traditional Chinese medicine, Brain-gut-lung axis, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tong-Fu-Xing-Shen herbal formula
Arm Type
Experimental
Arm 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.
Arm Title
The Placebo of Tong-Fu-Xing-Shen herbal formula
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tongfu capsules
Intervention Description
Tongfu capsules include 5 herbals
Intervention Type
Drug
Intervention Name(s)
The Placebo of Tongfu capsules
Intervention Description
The Placebo of Tongfu capsules are made from dextrin, starch and so on.
Primary Outcome Measure Information:
Title
the all-cause mortality rate
Description
Any cause of death
Time Frame
90±7 days
Title
the mortality of stroke associated pneumonia
Description
the death of stroke associated pneumonia
Time Frame
90±7 days
Secondary Outcome Measure Information:
Title
changes in the gut microbiota between the experiment group and the control group
Description
gut microbiota is monitored via 16S rRNA gene sequence analysis
Time Frame
Baseline (before drug), after drug 10-12 days
Title
National Institute of Health of stroke scale （NIHSS）
Description
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.
Time Frame
Baseline (before drug), after drug 10-12 days, 90±7 days
Title
Stroke Specific Quality Of Life scale (SS-QOL) (SS-QOL) score
Description
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.
Time Frame
90±7 days
Title
Barthel index
Description
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).
Time Frame
Baseline (before drug), after drug 10-12 days, 90±7 days
Title
Modified rankin scale (mRS)
Description
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.
Time Frame
after drug 10-12 days, 90±7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianwen Guo, doctor
Phone
0086-13724899379
Email
jianwen_guo@msn.com
First Name & Middle Initial & Last Name or Official Title & Degree
jianwen Guo, MD
Phone
(08620)81887233
Ext
30906
Email
306247680@qq.com
Facility Information:
Facility Name
Guangdong Province Hospital of Tradtional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianwen Guo, Dr
Phone
020-81887233
Ext
34530
Email
jianwen_guo@msn.com
First Name & Middle Initial & Last Name & Degree
Jianwen Guo, MD

12. IPD Sharing Statement

Learn more about this trial

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

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