Acute Ischemic StrokePhase 3AGNH2018NCT03733002
Efficacy and Safety of AngongNiuhuang Pill for the Treatment of Patients With Acute Ischemic Stroke.
A Phase 3 study testing AngongNiuhuang pill and Standard treatment in people with Acute Ischemic Stroke, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular, especially the cerebral vessels. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, reduce capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, improve oxidative… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- AngongNiuhuang pill and Standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 30 Dec 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke.
- 18 years ≤ age ≤ 80 years.
- Within 24 hours from symptom onset.
- Baseline NIHSS range 5 from 20.
- Provision of informed consent.
Who cannot join
- Not suitable for taking this medicine after dialectic of traditional Chinese medical doctor.
- Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases.
- Receive thrombolysis or endovascular treatment.
- mRS>1 at randomization (pre-morbid historical assessment).
- Thrombocytopenia(<100×10*9/L) , hematologic diseases and other systemic bleeding tendency.
- Sleepy head (GCS≤7).
Show all 14Show fewer
- Alanine transaminase > 1.5 times normal upper limit or Aspartate aminotransferase > 1.5 times normal upper limit.
- Glomerular filtration rate<60 ml/min/1.73m2.
- Patients who have been taking AngongNiuhuang pills within 3 months.
- Pregnancy or lactation, women in childbearing age with negative pregnancy test refuse to accept contraception.
- Participate in clinical studies of other research drugs within the last 30 days.
- Patients with a life expectancy of less than three months.
- Incapable to follow this study for mental illness, cognitive or emotional disorders.
- Unsuitable for this study in the opinion of the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Bin Peng
Beijing, Beijing Municipality, 100730
Shengde Li, MD, 86-17896002828, lishengde.medicine@qq.com
Bin Peng, MD, 86-10-69156371, pengbin3@hotmail.com
About this study
AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular, especially the cerebral vessels. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, reduce capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, improve oxidative stress injury, thus protecting brain tissue. Clinical studies have also confirmed that AngongNiuhuang pill can increase the GCS score, reduce coma, improve nerve function defect and promote nerve function recovery. The primary purpose of this trial was to evaluate the effect of AngongNiuhuang pill and placebo on the improvement of life function in patients with ischemic stroke at 90 days in acute phase.
Read the detailed description
This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multiple-center trial. A total of approximately 100 patients (18 years ≤age ≤80 years) within 24 hours of symptom onset of acute ischemic stroke, who shows NIHSS from 5-20 points. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive AngongNiuhuang pill 1 pill 1 times/day for 5-day; 2) the other group will receive Placebo of AngongNiuhuang pill 1 pill 1 times/day for 5-day.The primary purpose of this trial was to evaluate the effect of AngongNiuhuang pill and placebo on the improvement of life function in patients with ischemic stroke at 90 days in acute phase. The study consists of five visits including the day of randomization, 2-6 days, monitor daily temperature, 7 days when the therapy is done, 30 days, and 90 days when the follow-up is finished. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The improvement of life function will be assessed by Modified Rankin Scale(namely score=0-2). The trial is anticipated to last from July 2018 to December 2019 with 100 subjects recruited form 5 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese GCP standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study.
- Conditions
- Acute Ischemic Stroke
- Being tested
- AngongNiuhuang pill, Placebo of AngongNiuhuang pill, Standard treatment
- Keywords
- acute ischemic stroke, AngongNiuhuang pill
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngongNiuhuang pillDrug
This group will receive AngongNiuhuang pill 1 pill 1 times/day for 5-day.
Placebo of AngongNiuhuang pillDrug
This group will receive Placebo of AngongNiuhuang pill 1 pill 1 times/day for 5-day.
Standard treatmentOther
The other treatments according to guidelines for standard treatment of acute ischemic stroke.
| Study group | Role | What they receive |
|---|---|---|
| AngongNiuhuang | Experimental | Drugs: AngongNiuhuang pill. The other treatments will be provided according to guidelines for standard treatment of acute ischemic stroke. Receives: Drug: AngongNiuhuang pill; Other: Standard treatment |
| Placebo of AngongNiuhuang | Placebo comparator | Drugs: Placebo of AngongNiuhuang pill. The other treatments will be provided according to guidelines for standard treatment of acute ischemic stroke. Receives: Drug: Placebo of AngongNiuhuang pill; Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)
Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at the 90 days follow-up.
Measured: 90days
Severity Adverse Event
The percentage of the Severity Adverse Events within the 90 days of the therapy.
Measured: 90days
Secondary outcomes (9)
The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)
Modified Rankin Scale score changes (continuous) and dichotomized at percentage.
Measured: 7days, 30days
Neurological recovery
The recovery of neurological deficits assessed by the change of the 7days, 30 days and the 90 days NIHSS to the baseline NIHSS.
Measured: 7 days, 30 days,90 days
Barthel Index
Change in the score of the Barthel Index.（The Barthel Index (BI) measures 10 basic aspects of self-care and physical dependency, including 10 subscales: feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, mobility, and stairs. Every subscale ranges from 0 to 10. Its total score range is 0-100. A normal score is 100, and lower scores indicate increasing disability.）
Measured: 30 days, 90 days
Recurrent stroke, death and other vascular events
The quantity of patients who has recurrent stroke, death and other vascular events.
Measured: 30 days, 90 days
Changes of biomarker (hs-CRP)
Evaluation of the change in (centralization blood sample determination).
Measured: 7 days
Changes of biomarker (IL-10)
Evaluation of the change in IL-10 (centralization blood sample determination).
Measured: 7days
Changes of biomarker (TNF-α)
Evaluation of the change in TNF-α level (centralization blood sample determination).
Measured: 7days
Adverse Events
The percentage of the Adverse Events during the therapy.
Measured: 7 days, 90 days
Severity Adverse Event
The percentage of the Severity Adverse Events during the therapy.
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Cangzhou Central Hospital, The Second Hospital of Hebei Medical University, Affiliated Hospital of Chengde Medical University
- Responsible party
- Principal investigator, Bin Peng, Peking Union Medical College Hospital
- Investigators
- Bin Peng, MD, Principal investigator, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733002
- Sponsor's protocol ID
- PUMCH-AGNH2018
- Acronym
- AGNH2018
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of AngongNiuhuang Pill for the Treatment of Patients With Acute Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT03733002
- Acronym / sponsor ID
- AGNH2018 / PUMCH-AGNH2018
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, AngongNiuhuang pill
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Cangzhou Central Hospital, The Second Hospital of Hebei Medical University, Affiliated Hospital of Chengde Medical University
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 7 Nov 2018 (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.
AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular, especially the cerebral vessels. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, reduce capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, improve oxidative stress injury, thus protecting brain tissue. Clinical studies have also confirmed that AngongNiuhuang pill can increase the GCS score, reduce coma, improve nerve function defect and promote nerve function recovery. The primary purpose of this trial was to evaluate the effect of AngongNiuhuang pill and placebo on the improvement of life function in patients with ischemic stroke at 90 days in acute phase.
Detailed description
This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multiple-center trial. A total of approximately 100 patients (18 years ≤age ≤80 years) within 24 hours of symptom onset of acute ischemic stroke, who shows NIHSS from 5-20 points. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive AngongNiuhuang pill 1 pill 1 times/day for 5-day; 2) the other group will receive Placebo of AngongNiuhuang pill 1 pill 1 times/day for 5-day.The primary purpose of this trial was to evaluate the effect of AngongNiuhuang pill and placebo on the improvement of life function in patients with ischemic stroke at 90 days in acute phase. The study consists of five visits including the day of randomization, 2-6 days, monitor daily temperature, 7 days when the therapy is done, 30 days, and 90 days when the follow-up is finished. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The improvement of life function will be assessed by Modified Rankin Scale(namely score=0-2). The trial is anticipated to last from July 2018 to December 2019 with 100 subjects recruited form 5 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese GCP standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AngongNiuhuang | Experimental | Drug: AngongNiuhuang pill, Other: Standard treatmentDrugs: AngongNiuhuang pill. The other treatments will be provided according to guidelines for standard treatment of acute ischemic stroke. |
| Placebo of AngongNiuhuang | Placebo comparator | Drug: Placebo of AngongNiuhuang pill, Other: Standard treatmentDrugs: Placebo of AngongNiuhuang pill. The other treatments will be provided according to guidelines for standard treatment of acute ischemic stroke. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute ischemic stroke.
- 18 years ≤ age ≤ 80 years.
- Within 24 hours from symptom onset.
- Baseline NIHSS range 5 from 20.
- Provision of informed consent.
Key exclusion criteria (14 listed)
- Not suitable for taking this medicine after dialectic of traditional Chinese medical doctor.
- Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases.
- Receive thrombolysis or endovascular treatment.
- mRS>1 at randomization (pre-morbid historical assessment).
- Thrombocytopenia(<100×10*9/L) , hematologic diseases and other systemic bleeding tendency.
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 |
|---|---|---|
| AngongNiuhuang pillThis group will receive AngongNiuhuang pill 1 pill 1 times/day for 5-day. | Drug | AngongNiuhuang |
| Placebo of AngongNiuhuang pillThis group will receive Placebo of AngongNiuhuang pill 1 pill 1 times/day for 5-day. | Drug | Placebo of AngongNiuhuang |
| Standard treatmentThe other treatments according to guidelines for standard treatment of acute ischemic stroke. | Other | AngongNiuhuang, Placebo of AngongNiuhuang |
Primary outcome
The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)
Time frame: 90days
Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at the 90 days follow-up.
Severity Adverse Event
Time frame: 90days
The percentage of the Severity Adverse Events within the 90 days of the therapy.
9 secondary outcomes
The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)
Time frame: 7days, 30days
Neurological recovery
Time frame: 7 days, 30 days,90 days
Barthel Index
Time frame: 30 days, 90 days
Recurrent stroke, death and other vascular events
Time frame: 30 days, 90 days
Changes of biomarker (hs-CRP)
Time frame: 7 days
Changes of biomarker (IL-10)
Time frame: 7days
Changes of biomarker (TNF-α)
Time frame: 7days
Adverse Events
Time frame: 7 days, 90 days
Severity Adverse Event
Time frame: 7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Bin Peng, MD principal investigator
Peking Union Medical College
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 AngongNiuhuang pill and Standard treatment in people with Acute Ischemic Stroke, run by Peking Union Medical College 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 14 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 Nov 2018. 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 Shengde Li, MD (86-17896002828, lishengde.medicine@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2) (time frame: 90days). 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 Nov 2018.