- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04475328
Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke (ANGONG TRIAL)
September 8, 2023 updated by: Bin Peng, Peking Union Medical College Hospital
Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke
AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular diseases.
Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, inhibit capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, reduce 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 difference in the volume of cerebral infarction and cerebral edema between Angong Niuhuang pill and placebo in patients with ischemic stroke at 14 days compared with the baseline.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multicenter trial.
Patients who met the inclusion and exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive AngongNiuhuang pill 1pill qd/day for 5-day; 2) the other group will receive Placebo of AngongNiuhuang pill 1pill qd/day for 5-day.
The primary purpose of this trial was to evaluate the difference in the volume of cerebral infarction and cerebral edema between Angong Niuhuang pill and placebo in patients with ischemic stroke at 14 days compared with the baseline.
The study was consisted of six visits, including the day of randomization, 2 days, 3-6 days, 7 days (the endap time of the therapy), 14 days, and 90 days (the endap time of the follow-up).
Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program.
The period of the trial is from August 2020 to October 2021, and 120 subjects are planned to be recruited from 10 centers in China.
All the related investigative organizations and individuals will obey the Declaration of Helsinki and Chinese Guard-cell protoplast (GCP) standard.
A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shengde Li, MD
- Phone Number: 86-10-69154059
- Email: lishengde.medicine@qq.com
Study Contact Backup
- Name: Yan Zhao, MD
- Phone Number: 86-10-69154059
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100730
- Department of Neurology,Peking Union Medical College Hospital,Shuaifuyuan 1,Dong Cheng District. Beijing
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female participates aged 40-80 years.
- Diagnosis with acute ischemic stroke.
- Diagnosis with acute cerebral infarctions of internal carotid artery system.
- 10≤ Baseline NIHSS <20.
- Time of onset ≤36h.
- Provision of informed consent.
Exclusion Criteria:
- Not suitable for taking this medicine according to the judgement of consulting traditional Chinese medical doctor.
- Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases.
- Patients with hemorrhagic transformation after cerebral infarction.
- Received or planned to receive endovascular treatment, including thrombectomy, ultra early thrombectomy and stenting.
- Received or planned to receive decompression craniectomy.
- With mRS score >1 before onset of this episode.
- Participates who cannot tolerate the MRI scans, such as Using a pacemaker or automatic defibrillator or having claustrophobia.
- With thrombocytopenia (<100 x10^9/L), hematologic diseases or other systemic bleeding tendency.
- With Alanine transaminase or Aspartate aminotransferase >1.5 times than normal upper limit or Creatinine >1.5 times than normal upper limit.
- Allergic to ingredients of AngongNiuhuang pill.
- Received AngongNiuhuang pill within 1 month.
- Participates who plan to become pregnant within 3 months, or women of childbearing age with negative pregnancy test but refuse to accept contraception; during pregnancy or lactation.
- Participates in other clinical trials within 30 days before randomization or currently involved in other clinical trails.
- Participates with a life expectancy less than 3 months.
- Incapable to follow this study due to mental illness, cognitive or emotional disorders.
- Participates are not eligible for this clinical trial as evaluated by the investigators.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AngongNiuhuang
Drugs : AngongNiuhuang pill.
The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke.
|
This group will receive AngongNiuhuang pill 1pill qd/day for 5-day.
Other Names:
The other treatments according to guidelines for standard treatment of acute ischemic stroke
|
Placebo Comparator: Placebo of AngongNiuhuang
Drugs : Placebo of AngongNiuhuang pill.
The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke.
|
The other treatments according to guidelines for standard treatment of acute ischemic stroke
This group will receive placebo of AngongNiuhuang pill 1pill qd/day for 5-day.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral infarction volume
Time Frame: 14 days
|
Changes in cerebral infarction volume on Day 14 of the treatment from baseline.
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14 days
|
Cerebral edema volume
Time Frame: 14 days
|
Changes in cerebral edema volume on Day 14 of the treatment from baseline.
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14 days
|
The proportion of the patients with Severity Adverse Events within 90 days of the treatment.
Time Frame: 90 days
|
Severity Adverse Events
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral infarction volume
Time Frame: 90 days
|
Changes in cerebral infarction volume on Day 90 of the treatment from baseline.
|
90 days
|
Cerebral edema volume
Time Frame: 90 days
|
Changes in cerebral edema volume on Day 90 of the treatment from baseline.
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90 days
|
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point on the Day 14 and 90 of treatment.
Time Frame: 14 days, 90 days
|
Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
0 - No symptoms.1 - No significant disability.
Able to carry out all usual activities, despite some symptoms.2
- Slight disability.
Able to look after own affairs without assistance, but unable to carry out all previous activities.3
- Moderate disability.
Requires some help, but able to walk unassisted.4 - Moderately severe disability.
Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability.
Requires constant nursing care and attention, bedridden, incontinent.6 - Dead.
The mRS scores between 3 to 6 points are considered to be poor functional outcome.
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14 days, 90 days
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Changes in NIHSS score on Day 14 and 90 of the treatment from baseline.
Time Frame: 14 days, 90 days
|
The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke.
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
The individual scores from each item are summed in order to calculate a patient's total NIHSS score.
The maximum possible score is 42, with the minimum score being a 0.
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14 days, 90 days
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Changes in Glasgow Coma Score (GCS) on the Day 7 and 14 of the treatment from baseline.
Time Frame: 7 days, 14 days
|
We will use the GCS score to evaluate the degree of coma.
The GCS have three domain items (open-eye response, speech response, and movement).
The maximum possible score is 15, with the minimum score being a 3.
|
7 days, 14 days
|
Changes of biomarker (hs-CRP)
Time Frame: 7 days
|
Evaluation of the change in hs-CRP on Day 7 of the treatment.
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7 days
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Changes of biomarker (MMP-9)
Time Frame: 7 days
|
Evaluation of the change in MMP-9 on Day 7 of the treatment.
|
7 days
|
Changes of biomarker (S-100B)
Time Frame: 7 days
|
Evaluation of the change in S-100B on Day 7 of the treatment.
|
7 days
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Changes of biomarker (NSE)
Time Frame: 7 days
|
Evaluation of the change in NSE on Day 7 of the treatment.
|
7 days
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The proportion of the patients with Severity Adverse Events within 7 days of the treatment.
Time Frame: 7 days
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Severity Adverse Events
|
7 days
|
Changes in toxicology index including mercury and arsenic on Day 7 of the treatment.
Time Frame: 7 days
|
toxicology index
|
7 days
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The proportion of the patients with Adverse Events within 7 and 90 days of the treatment.
Time Frame: 7 days, 90 days
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Adverse Events
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7 days, 90 days
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The proportion of the patients with All-cause mortality within 7 and 90 days of the treatment.
Time Frame: 7 days, 90 days
|
All-cause mortality
|
7 days, 90 days
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The proportion of the patients with Combined vascular events within 7 and 90 days of the treatment.
Time Frame: 7 days, 90 days
|
Combined vascular events
|
7 days, 90 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bin Peng, MD, Peking Union Medical College Hosptial, Chinese Academy of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
July 30, 2022
Study Registration Dates
First Submitted
July 10, 2020
First Submitted That Met QC Criteria
July 16, 2020
First Posted (Actual)
July 17, 2020
Study Record Updates
Last Update Posted (Actual)
September 11, 2023
Last Update Submitted That Met QC Criteria
September 8, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUMCH-AGNH2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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