- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03733002
Efficacy and Safety of AngongNiuhuang Pill for the Treatment of Patients With Acute Ischemic Stroke. (AGNH2018)
November 6, 2018 updated by: Bin Peng, Peking Union Medical College Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
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: 86-17896002828
- Email: lishengde.medicine@qq.com
Study Contact Backup
- Name: Bin Peng, MD
- Phone Number: 86-10-69156371
- Email: pengbin3@hotmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Bin Peng
-
Contact:
- Shengde Li, MD
- Phone Number: 86-17896002828
- Email: lishengde.medicine@qq.com
-
Contact:
- Bin Peng, MD
- Phone Number: 86-10-69156371
- Email: pengbin3@hotmail.com
-
Sub-Investigator:
- Zunjing Liu, MD
-
Sub-Investigator:
- Rusheng Shao, MD
-
Sub-Investigator:
- Zhenzhong Li, MD
-
Sub-Investigator:
- Yanjun Gao, MD
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Acute ischemic stroke.
- 18 years ≤ age ≤ 80 years.
- Within 24 hours from symptom onset.
- Baseline NIHSS range 5 from 20.
- Provision of informed consent.
Exclusion Criteria:
- 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).
- 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.
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 be provided according to guidelines for standard treatment of acute ischemic stroke.
|
This group will receive AngongNiuhuang pill 1 pill 1 times/day for 5-day.
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 be 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 1 pill 1 times/day for 5-day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
90days
|
Severity Adverse Event
Time Frame: 90days
|
The percentage of the Severity Adverse Events within the 90 days of the therapy.
|
90days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)
Time Frame: 7days, 30days
|
Modified Rankin Scale score changes (continuous) and dichotomized at percentage.
|
7days, 30days
|
Neurological recovery
Time Frame: 7 days, 30 days,90 days
|
The recovery of neurological deficits assessed by the change of the 7days, 30 days and the 90 days NIHSS to the baseline NIHSS.
|
7 days, 30 days,90 days
|
Barthel Index
Time Frame: 30 days, 90 days
|
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.)
|
30 days, 90 days
|
Recurrent stroke, death and other vascular events
Time Frame: 30 days, 90 days
|
The quantity of patients who has recurrent stroke, death and other vascular events.
|
30 days, 90 days
|
Changes of biomarker (hs-CRP)
Time Frame: 7 days
|
Evaluation of the change in (centralization blood sample determination).
|
7 days
|
Changes of biomarker (IL-10)
Time Frame: 7days
|
Evaluation of the change in IL-10 (centralization blood sample determination).
|
7days
|
Changes of biomarker (TNF-α)
Time Frame: 7days
|
Evaluation of the change in TNF-α level (centralization blood sample determination).
|
7days
|
Adverse Events
Time Frame: 7 days, 90 days
|
The percentage of the Adverse Events during the therapy.
|
7 days, 90 days
|
Severity Adverse Event
Time Frame: 7days
|
The percentage of the Severity Adverse Events during the therapy.
|
7days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Bin Peng, MD, Peking Union Medical College
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 (Anticipated)
December 1, 2018
Primary Completion (Anticipated)
December 30, 2019
Study Completion (Anticipated)
December 30, 2019
Study Registration Dates
First Submitted
November 1, 2018
First Submitted That Met QC Criteria
November 6, 2018
First Posted (Actual)
November 7, 2018
Study Record Updates
Last Update Posted (Actual)
November 7, 2018
Last Update Submitted That Met QC Criteria
November 6, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUMCH-AGNH2018
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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