Intracerebral HemorrhagePhase 3NCT05066620
Chinese Herbal Medicine in Acute INtracerebral Haemorrhage (CHAIN) Trial
A Phase 3 study testing Chinese herbal medicine FYTF-919 in people with Intracerebral Hemorrhage, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine FYTF-919 in reducing haematoma and bleeding after acute ICH from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Chinese herbal medicine FYTF-919
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,504 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Jan 2025
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Diagnosis of spontaneous ICH, confirmed by brain imaging;
- Presentation within 48 hours of symptom onset (or last seen well);
- Meet any of the following criteria: a) NIHSS ≥8, or b) GCS 7-14;
- Provide written informed consent by patient (or approved surrogate);
Who cannot join
- ICH secondary to a structural abnormality in the brain (e.g. cerebrovascular malformation, arterial aneurysm, tumour, Moyamoya disease, trauma, or previous ischaemic stroke), or secondary to presumed cerebrovascular amyloidosis, or secondary to reperfusion treatment for ischaemic stroke, or secondary to anticoagulant treatment, or secondary to antiplatelet treatment.
- Unlikely to potentially benefit from therapy (e.g. advanced dementia) or judged by responsible treating clinician to have a high likelihood of early death irrespective of treatment;
- Other medical illness that will interfere with outcome assessments and follow-up (e.g. known significant pre-stroke disability [modified Rankin scale {mRS} scores 4-5], advanced cancer and renal failure);
- Known definite contraindication to the Chinese herbal medicine;
- Women who are known to be pregnant or lactating;
- Currently participating in another trial which would interfere with outcome assessments.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong
Jianwen Guo, MD, +86 13724899379, jianwen_guo@qq.com
Lily Song, PhD, +86 13916466400, lsong@georgeinstitute.org.cn
About this study
Official title: An Investigator-initiated and Conducted Multicentre, Prospective, Randomised, Double-blinded Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Chinese Herbal Medicine in Patients With Acute Intracerebral Haemorrhage
TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine FYTF-919 in reducing haematoma and bleeding after acute ICH from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study aims to determine the effectiveness and safety of TCM in a larger sample of patients with moderate-severe ICH and provide evidence for TCM clinical guidelines on ICH management. The presumed mechanism of action is in promoting the reabsorption of the haematoma and perihematomal oedema in ICH.
Read the detailed description
A multicentre, prospective, randomised, double-blind, placebo-controlled trial to be conducted through hospital network of investigators in China. A total of 1504 patients with ICH will be recruited from approximately 20-30 hospitals. Randomised is via a central internet-based system according to block random grouping method stratified by site, neurological severity NIHSS <15 vs ≥15), and haematoma location (basal ganglia + lobe vs thalamus + cerebellum + brain stem + ventricle) to ensure balance in key prognostic factors. Endpoint assessment will be blinded to treatment allocation. The primary aim of this study is to determine the effectiveness and safety of a Chinese herbal medicine FYTF-919 as compared to placebo on functional recovery according to Utility-weighted modified Rankin scale (UW-mRS) at 90 days after acute ICH. Secondary aims include examining whether the Chinese herbal medicine FYTF-919 leads to positive treatment effect on: 1) Utility-weighted mRS scores at 180 days; 2)Ordinal analysis of 7 levels of mRS at 28 days, 90 days and 180 days; 3) Poor prognosis, defined as mRS 4-6 points at 28 days, 90 days and 180 days; 4) NIHSS score at 7 days and 28 days; 5) Mortality rate at 28 days, 90 days and 180 days; 6) Discharge rate at 28 days; 7) EQ-5D-5L at 28days, 90 days and 180 days; 8) BI at 28 days, 90 days and 180 days; 9) The cerebral edema volume at baseline, 24 hours, 7 days, 14 days or at discharge; 10) The hematoma volume at baseline, 24 hours, 7 days, 14 days or discharge; 11) The incidence of stroke-associated pneumonia (SAP) patients; 12) Clinical pulmonary infection score (CIPS) at the onset of SAP, 3 days, and 7 days, after the occurrence of SAP; 13) Chest imaging (DR/CT), body temperature, white blood cell count, C-reactive protein (CRP), procalcitonin (PCT) blood gas analysis, and sputum culture/airway aspirate culture at the onset of SAP, 3 days, and 7 days after the occurrence of SAP; 14) Antibiotic usage among patients with SAP.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Chinese herbal medicine FYTF-919
- Keywords
- Intracerebral haemorrhage, Functional recovery, Chinese herbal medicine, Stroke, Clinical trial
- Medical subject headings
- Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal medicine FYTF-919Drug
Also called Chinese herbal medicine
Oral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml * Q6H will be given through nasal feeding)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Chinese herbal medicine FYTF-919: Oral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml * Q6H will be given through nasal feeding) Receives: Drug: Chinese herbal medicine FYTF-919 |
| Control group | Placebo comparator | Placebo treatment: Oral liquid 33ml TID (or patients who are unconscious or dysphagia, a dose of 25ml * Q6H will be given through nasal feeding) Receives: Drug: Chinese herbal medicine FYTF-919 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility-weighted modified Rankin scale scores
Utility-weighted modified Rankin scale scores. The value range from 0 to 10: higher scores mean a better outcome.
Measured: 90 days after the treatment started
Secondary outcomes (14)
Utility-weighted mRS scores
Utility-weighted modified Rankin scale scores. The value range from 0 to 10: higher scores mean a better outcome.
Measured: 180 days after the treatment started
7 levels of mRS
Ordinal analysis of 7 levels of mRS. The value range 0-6: higher scores mean a worse outcome.
Measured: 28 days, 90 days and 180 days after the treatment started
Poor prognosis rate
Binary variable: 1 means mRS 4-6 points; 0 means mRS is 0-3 points.
Measured: 28 days, 90 days and 180 days after the treatment started
NIHSS score
National Institute of Health Stroke Scale Score. The value range 0-42: higher scores mean a worse outcome.
Measured: 7 days and 28 days after the treatment started
Mortality rate
Mortality rate
Measured: 28 days, 90 days and 180 days
Discharge rate
Discharge rate
Measured: 28 days after the treatment started
European Quality of Life 5-dimensional questionnaire (EQ-5D-5L)
The EQ-5D comprises five dimensions of health: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression. . EQ-5D-5L, includes five levels of severity for each dimension (no problems, slight problems, moderate problems, severe problems, and extreme problems). The value range 0-100: higher scores mean a worse outcome.
Measured: 28 days, 90 days and 180 days after the treatment started
BI
Barthel index. The value range 0-100: higher scores mean a better outcome.
Measured: 28 days, 90 days and 180 days after the treatment started
The cerebral edema volume
The cerebral edema volume
Measured: Baseline, 24 hours, 7 days, 14 days or at discharge
The hematoma volume
The hematoma volume
Measured: Baseline, 24 hours, 7 days, 14 days or discharge
SAP
The incidence of stroke-associated pneumonia patients
Measured: Baseline, 24 hours, 7 days, 14 days or discharge
CPIS
Clinical pulmonary infection score. The value range 0-12: higher scores mean a worse outcome.
Measured: The onset of SAP, 3 days and 7 days after the occurrence of SAP
Pulmonary infection
Diagnosed by using the Chest imaging (DR/CT), body temperature, white blood cell count, C-reactive protein (CRP), procalcitonin (PCT) blood gas analysis, and sputum culture/airway aspirate culture
Measured: The onset of SAP, 3 days and 7 days after the occurrence of SAP
Antibiotic usage
Antibiotic usage among patients with SAP
Measured: The onset of SAP, 3 days and 7 days after the occurrence of SAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The George Institute
- Responsible party
- Principal investigator, jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine
- Investigators
- Craig Anderson, MD, Principal investigator, The George Institute for Global Health, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066620
- Sponsor's protocol ID
- 2020B1111100009
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to the research office of The George Institute for Global Health, Sydney Australia.
Publications
Guo J, Chen X, Wu M, Wang D, Zhao Y, Li Q, Tang G, Che F, Xia Z, Liang Z, Shi L, Jiang Q, Chen Y, Liu X, Ren X, Ouyang M, Wang B, You S, Billot L, Wang X, Liu Z, Jing H, Meng W, Tian S, Liu E, Xiang Y, Tang X, Xie T, Cui W, Zheng Y, Cao J, Zhang J, Wen Z, Huang T, Wang L, You C, Pan S, Cai Y, Lu Y, Hankey GJ, Al-Shahi Salman R, Anderson CS, Song L; CHAIN investigators. Traditional Chinese medicine FYTF-919 (Zhongfeng Xingnao oral prescription) for the treatment of acute intracerebral haemorrhage: a multicentre, randomised, placebo-controlled, double-blind, clinical trial. Lancet. 2024 Nov 30;404(10468):2187-2196. doi: 10.1016/S0140-6736(24)02261-X. Epub 2024 Nov 12.
PubMed 39547249
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated and Conducted Multicentre, Prospective, Randomised, Double-blinded Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Chinese Herbal Medicine in Patients With Acute Intracerebral Haemorrhage
- ClinicalTrials.gov ID
- NCT05066620
- Acronym / sponsor ID
- 2020B1111100009
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral haemorrhage, Functional recovery, Chinese herbal medicine, Stroke, Clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,504 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The George Institute
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 4 Oct 2021 (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.
TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine FYTF-919 in reducing haematoma and bleeding after acute ICH from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study aims to determine the effectiveness and safety of TCM in a larger sample of patients with moderate-severe ICH and provide evidence for TCM clinical guidelines on ICH management. The presumed mechanism of action is in promoting the reabsorption of the haematoma and perihematomal oedema in ICH.
Detailed description
A multicentre, prospective, randomised, double-blind, placebo-controlled trial to be conducted through hospital network of investigators in China. A total of 1504 patients with ICH will be recruited from approximately 20-30 hospitals. Randomised is via a central internet-based system according to block random grouping method stratified by site, neurological severity NIHSS <15 vs ≥15), and haematoma location (basal ganglia + lobe vs thalamus + cerebellum + brain stem + ventricle) to ensure balance in key prognostic factors. Endpoint assessment will be blinded to treatment allocation. The primary aim of this study is to determine the effectiveness and safety of a Chinese herbal medicine FYTF-919 as compared to placebo on functional recovery according to Utility-weighted modified Rankin scale (UW-mRS) at 90 days after acute ICH. Secondary aims include examining whether the Chinese herbal medicine FYTF-919 leads to positive treatment effect on: 1) Utility-weighted mRS scores at 180 days; 2)Ordinal analysis of 7 levels of mRS at 28 days, 90 days and 180 days; 3) Poor prognosis, defined as mRS 4-6 points at 28 days, 90 days and 180 days; 4) NIHSS score at 7 days and 28 days; 5) Mortality rate at 28 days, 90 days and 180 days; 6) Discharge rate at 28 days; 7) EQ-5D-5L at 28days, 90 days and 180 days; 8) BI at 28 days, 90 days and 180 days; 9) The cerebral edema volume at baseline, 24 hours, 7 days, 14 days or at discharge; 10) The hematoma volume at baseline, 24 hours, 7 days, 14 days or discharge; 11) The incidence of stroke-associated pneumonia (SAP) patients; 12) Clinical pulmonary infection score (CIPS) at the onset of SAP, 3 days, and 7 days, after the occurrence of SAP; 13) Chest imaging (DR/CT), body temperature, white blood cell count, C-reactive protein (CRP), procalcitonin (PCT) blood gas analysis, and sputum culture/airway aspirate culture at the onset of SAP, 3 days, and 7 days after the occurrence of SAP; 14) Antibiotic usage among patients with SAP.
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 |
|---|---|---|
| Intervention group | Experimental | Drug: Chinese herbal medicine FYTF-919Chinese herbal medicine FYTF-919: Oral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml * Q6H will be given through nasal feeding) |
| Control group | Placebo comparator | Drug: Chinese herbal medicine FYTF-919Placebo treatment: Oral liquid 33ml TID (or patients who are unconscious or dysphagia, a dose of 25ml * Q6H will be given through nasal feeding) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years;
- Diagnosis of spontaneous ICH, confirmed by brain imaging;
- Presentation within 48 hours of symptom onset (or last seen well);
- Meet any of the following criteria: a) NIHSS ≥8, or b) GCS 7-14;
- Provide written informed consent by patient (or approved surrogate);
Key exclusion criteria (6 listed)
- ICH secondary to a structural abnormality in the brain (e.g. cerebrovascular malformation, arterial aneurysm, tumour, Moyamoya disease, trauma, or previous ischaemic stroke), or secondary to presumed cerebrovascular amyloidosis, or secondary to reperfusion treatment for ischaemic stroke, or secondary to anticoagulant treatment, or secondary to antiplatelet treatment.
- Unlikely to potentially benefit from therapy (e.g. advanced dementia) or judged by responsible treating clinician to have a high likelihood of early death irrespective of treatment;
- Other medical illness that will interfere with outcome assessments and follow-up (e.g. known significant pre-stroke disability [modified Rankin scale {mRS} scores 4-5], advanced cancer and renal failure);
- Known definite contraindication to the Chinese herbal medicine;
- Women who are known to be pregnant or lactating;
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 |
|---|---|---|
| Chinese herbal medicine FYTF-919Also: Chinese herbal medicineOral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml * Q6H will be given through nasal feeding) | Drug | Control group, Intervention group |
Primary outcome
Utility-weighted modified Rankin scale scores
Time frame: 90 days after the treatment started
Utility-weighted modified Rankin scale scores. The value range from 0 to 10: higher scores mean a better outcome.
14 secondary outcomes
Utility-weighted mRS scores
Time frame: 180 days after the treatment started
7 levels of mRS
Time frame: 28 days, 90 days and 180 days after the treatment started
Poor prognosis rate
Time frame: 28 days, 90 days and 180 days after the treatment started
NIHSS score
Time frame: 7 days and 28 days after the treatment started
Mortality rate
Time frame: 28 days, 90 days and 180 days
Discharge rate
Time frame: 28 days after the treatment started
European Quality of Life 5-dimensional questionnaire (EQ-5D-5L)
Time frame: 28 days, 90 days and 180 days after the treatment started
BI
Time frame: 28 days, 90 days and 180 days after the treatment started
The cerebral edema volume
Time frame: Baseline, 24 hours, 7 days, 14 days or at discharge
The hematoma volume
Time frame: Baseline, 24 hours, 7 days, 14 days or discharge
SAP
Time frame: Baseline, 24 hours, 7 days, 14 days or discharge
CPIS
Time frame: The onset of SAP, 3 days and 7 days after the occurrence of SAP
Pulmonary infection
Time frame: The onset of SAP, 3 days and 7 days after the occurrence of SAP
Antibiotic usage
Time frame: The onset of SAP, 3 days and 7 days after the occurrence of SAP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Derived from this study: PubMed 39547249Guo J, Chen X, Wu M, Wang D, Zhao Y, Li Q, Tang G, Che F, Xia Z, Liang Z, Shi L, Jiang Q, Chen Y, Liu X, Ren X, Ouyang M, Wang B, You S, Billot L, Wang X, Liu Z, Jing H, Meng W, Tian S, Liu E, Xiang Y, Tang X, Xie T, Cui W, Zheng Y, Cao J, Zhang J, Wen Z, Huang T, Wang L, You C, Pan S, Cai Y, Lu Y, Hankey GJ, Al-Shahi Salman R, Anderson CS, Song L; CHAIN investigators. Traditional Chinese medicine FYTF-919 (Zhongfeng Xingnao oral prescription) for the treatment of acute intracerebral haemorrhage: a multicentre, randomised, placebo-controlled, double-blind, clinical trial. Lancet. 2024 Nov 30;404(10468):2187-2196. doi: 10.1016/S0140-6736(24)02261-X. Epub 2024 Nov 12.
- Individual participant dataSharing planned: Yes. Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to the research office of The George Institute for Global Health, Sydney Australia.
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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.
Craig Anderson, MD principal investigator
The George Institute for Global Health, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chinese herbal medicine FYTF-919 in people with Intracerebral Hemorrhage, 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 5 inclusion and 6 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 4 Oct 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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, MD (+86-13724899379, jianwen_guo@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility-weighted modified Rankin scale scores (time frame: 90 days after the treatment started). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05066620, which also lists 1 linked publication.
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 4 Oct 2021.