StrokePhase 4TFXSHFNCT04275219
Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia
A Phase 4 study testing Tongfu capsules in people with Stroke and Complication, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Complication
- What is being tested?
- Tongfu capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2019to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, 510120
jianwen Guo, Dr, 020-81887233 ext. 34530, jianwen_guo@msn.com
Jianwen Guo, MD
About this study
Official title: Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia (TFXSHF)
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.
Read the 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.
- Conditions
- Stroke, Complication
- Being tested
- Tongfu capsules, The Placebo of Tongfu capsules
- Keywords
- stroke-associated pneumonia, Tong-Fu-Xing-Shen herbal formula, Traditional Chinese medicine, Brain-gut-lung axis, Randomized controlled trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongfu capsulesDrug
Tongfu capsules include 5 herbals
The Placebo of Tongfu capsulesDrug
The Placebo of Tongfu capsules are made from dextrin, starch and so on.
| Study group | Role | What they receive |
|---|---|---|
| Tong-Fu-Xing-Shen herbal formula | Experimental | Tong-Fu-Xing-Shen herbal formula prescription (0.4g*36 capsules/bottle，1-4 capsules each time, three times a day.) for 10-12days. Receives: Drug: Tongfu capsules |
| The Placebo of Tong-Fu-Xing-Shen herbal formula | Placebo comparator | 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. Receives: Drug: The Placebo of Tongfu capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
the all-cause mortality rate
Any cause of death
Measured: 90±7 days
the mortality of stroke associated pneumonia
the death of stroke associated pneumonia
Measured: 90±7 days
Secondary outcomes (5)
changes in the gut microbiota between the experiment group and the control group
gut microbiota is monitored via 16S rRNA gene sequence analysis
Measured: Baseline (before drug), after drug 10-12 days
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.
Measured: Baseline (before drug), after drug 10-12 days, 90±7 days
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.
Measured: 90±7 days
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).
Measured: Baseline (before drug), after drug 10-12 days, 90±7 days
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.
Measured: after drug 10-12 days, 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start15 Mar 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275219
- Sponsor's protocol ID
- 001/20180101
- Acronym
- TFXSHF
- Status last verified
- May 2020
- First submitted
- 11 Feb 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia (TFXSHF)
- ClinicalTrials.gov ID
- NCT04275219
- Acronym / sponsor ID
- TFXSHF / 001/20180101
- Conditions
- Stroke, Complication
- Keywords
- stroke-associated pneumonia, Tong-Fu-Xing-Shen herbal formula, Traditional Chinese medicine, Brain-gut-lung axis, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- 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
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tong-Fu-Xing-Shen herbal formula | Experimental | Drug: Tongfu capsulesTong-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 | Placebo comparator | Drug: The Placebo of Tongfu capsulesThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongfu capsulesTongfu capsules include 5 herbals | Drug | Tong-Fu-Xing-Shen herbal formula |
| The Placebo of Tongfu capsulesThe Placebo of Tongfu capsules are made from dextrin, starch and so on. | Drug | The Placebo of Tong-Fu-Xing-Shen herbal formula |
Primary outcome
the all-cause mortality rate
Time frame: 90±7 days
Any cause of death
the mortality of stroke associated pneumonia
Time frame: 90±7 days
the death of stroke associated pneumonia
5 secondary outcomes
changes in the gut microbiota between the experiment group and the control group
Time frame: Baseline (before drug), after drug 10-12 days
National Institute of Health of stroke scale （NIHSS）
Time frame: Baseline (before drug), after drug 10-12 days, 90±7 days
Stroke Specific Quality Of Life scale (SS-QOL) (SS-QOL) score
Time frame: 90±7 days
Barthel index
Time frame: Baseline (before drug), after drug 10-12 days, 90±7 days
Modified rankin scale (mRS)
Time frame: after drug 10-12 days, 90±7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tongfu capsules in people with Stroke and Complication, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianwen Guo, doctor (0086-13724899379, jianwen_guo@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the all-cause mortality rate (time frame: 90±7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.