Acute Hemorrhagic StrokePhase 4NCT04946474
Clinical Evaluation of the Combination of Symptoms and Symptoms With General Treatment for Acute Hemorrhagic Stroke
A Phase 4 study testing Xingnaojing injection + Shuxuetong oral liquid in people with Acute Hemorrhagic Stroke, run by Peking University Third Hospital at 1 site in China.
Trial summary
Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage. Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Hemorrhagic Stroke
- What is being tested?
- Xingnaojing injection + Shuxuetong oral liquid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ① It meets the diagnostic criteria of primary cerebral hemorrhage.
- Within 72 hours of onset.
- National Institutes of Health Stroke Scale (NIHSS) score ≥4 points.
- ④ Glasgow Coma Scale (GCS) score \> Eight points.
- ⑤ Age 18-80. Patient or legal representative informed consent, and sign informed consent.
Who cannot join
- (1) known to Xingnaojing, cerebral hemorrhage or related drug ingredients allergic.
- The patients with previous stroke history and remaining sequelae affected the outcome assessment, that is, the modified Ranking scale (MRS) score before the onset of stroke was ≥2 points.
- known by amyloid cerebrovascular disease, vascular malformation, aneurysm, blood coagulation dysfunction, anticoagulation and antiplatelet drug treatment, thrombolysis therapy, bleeding after infarction after conversion, haematology, moyamoya disease, primary or metastatic tumor, venous sinus thrombosis, and vascular inflammation caused by clear etiology of patients with cerebral hemorrhage or primary intraventricular hemorrhage.
- (Note: "After anticoagulant or antiplatelet therapy" refers to patients with intracerebral hemorrhage following anticoagulant and antiplatelet therapy, and these patients were excluded from this study.) (4) Patients with traumatic cerebral hemorrhage. (5) patients with active gastrointestinal ulcer or other definite tendency of rebleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation and Study on the Combination of Disease and Syndrome With General Treatment for Acute Hemorrhagic Stroke
Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage.
Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage
Read the detailed description
Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage.
Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage Statistical Methods: The main effective outcomes will be based on a generalized linear model and adjusted for associated confounders.
- Conditions
- Acute Hemorrhagic Stroke
- Being tested
- Xingnaojing injection + Shuxuetong oral liquid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xingnaojing injection + Shuxuetong oral liquidDrug
Xingnaojing injection (administered immediately after joining the group, once a day, treatment for 10 days) + Naoxueshu oral liquid treatment (administered on the 4th day of onset, 3 times a day, treatment for 30 days ).
| Study group | Role | What they receive |
|---|---|---|
| Xingnaojing injection + Shuxuetong oral liquid | Experimental | Xingnaojing injection (administered immediately after joining the group, once a day, treatment for 10 days) + Naoxueshu oral liquid treatment (administered on the 4th day of onset, 3 times a day, treatment for 30 days ). Receives: Drug: Xingnaojing injection + Shuxuetong oral liquid |
| Placebo group | Placebo comparator | Xingnaojing injection simulation agent + Naoxueshu oral liquid simulation agent treatment was given. Receives: Drug: Xingnaojing injection + Shuxuetong oral liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-care
90 days of self-care (mRS 0-2 points)
Measured: after 90 days
Secondary outcomes (1)
NIHSS
NIHSS score improvement on day 14 of onset
Measured: on day 14 of onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Jun 2019
- Primary completion1 Jul 2020
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hemorrhagic StrokeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946474
- Sponsor's protocol ID
- M2019412
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation and Study on the Combination of Disease and Syndrome With General Treatment for Acute Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT04946474
- Acronym / sponsor ID
- M2019412
- Conditions
- Acute Hemorrhagic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 30 Jun 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.
Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage.
Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage
Detailed description
Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage.
Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage Statistical Methods: The main effective outcomes will be based on a generalized linear model and adjusted for associated confounders.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xingnaojing injection + Shuxuetong oral liquid | Experimental | Drug: Xingnaojing injection + Shuxuetong oral liquidXingnaojing injection (administered immediately after joining the group, once a day, treatment for 10 days) + Naoxueshu oral liquid treatment (administered on the 4th day of onset, 3 times a day, treatment for 30 days ). |
| Placebo group | Placebo comparator | Drug: Xingnaojing injection + Shuxuetong oral liquidXingnaojing injection simulation agent + Naoxueshu oral liquid simulation agent treatment was given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ① It meets the diagnostic criteria of primary cerebral hemorrhage.
- ④ Glasgow Coma Scale (GCS) score \> Eight points.
- ⑤ Age 18-80. Patient or legal representative informed consent, and sign informed consent.
Key exclusion criteria (4 listed)
- (1) known to Xingnaojing, cerebral hemorrhage or related drug ingredients allergic.
- (Note: "After anticoagulant or antiplatelet therapy" refers to patients with intracerebral hemorrhage following anticoagulant and antiplatelet therapy, and these patients were excluded from this study.) (4) Patients with traumatic cerebral hemorrhage. (5) patients with active gastrointestinal ulcer or other definite tendency of rebleeding.
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 |
|---|---|---|
| Xingnaojing injection + Shuxuetong oral liquidXingnaojing injection (administered immediately after joining the group, once a day, treatment for 10 days) + Naoxueshu oral liquid treatment (administered on the 4th day of onset, 3 times a day, treatment for 30 days ). | Drug | Placebo group, Xingnaojing injection + Shuxuetong oral liquid |
Primary outcome
self-care
Time frame: after 90 days
90 days of self-care (mRS 0-2 points)
1 secondary outcome
NIHSS
Time frame: on day 14 of onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Xingnaojing injection + Shuxuetong oral liquid in people with Acute Hemorrhagic Stroke, run by Peking University Third Hospital 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 4 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 30 Jun 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-care (time frame: after 90 days). 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 30 Jun 2021.