A Phase 3 interventional study of AngongNiuhuang pill and Placebo of AngongNiuhuang pill in Acute Ischemic Stroke, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Peking Union Medical College Hospital · Phase 3, Interventional, and Treatment
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.
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.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's enrollment of 120 is close to the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Drugs : AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke.
Drug: AngongNiuhuang pill · Other: Standard treatment
Drugs : Placebo of AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke.
Drug: Placebo of AngongNiuhuang pill · Other: Standard treatment
This group will receive AngongNiuhuang pill 1pill qd/day for 5-day.
Also known as: Angong Niuhuang Wan
This group will receive placebo of AngongNiuhuang pill 1pill qd/day for 5-day.
Also known as: Placebo of Angong Niuhuang Wan
The other treatments according to guidelines for standard treatment of acute ischemic stroke
Cerebral infarction volume
Changes in cerebral infarction volume on Day 14 of the treatment from baseline.
Time frame: 14 days
Cerebral edema volume
Changes in cerebral edema volume on Day 14 of the treatment from baseline.
Time frame: 14 days
The proportion of the patients with Severity Adverse Events within 90 days of the treatment.
Severity Adverse Events
Time frame: 90 days
Cerebral infarction volume
Changes in cerebral infarction volume on Day 90 of the treatment from baseline.
Time frame: 90 days
Cerebral edema volume
Changes in cerebral edema volume on Day 90 of the treatment from baseline.
Time frame: 90 days
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point on the Day 14 and 90 of treatment.
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.
Time frame: 14 days, 90 days
Changes in NIHSS score on Day 14 and 90 of the treatment from baseline.
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.
Time frame: 14 days, 90 days
Changes in Glasgow Coma Score (GCS) on the Day 7 and 14 of the treatment from baseline.
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.
Time frame: 7 days, 14 days
Changes of biomarker (hs-CRP)
Evaluation of the change in hs-CRP on Day 7 of the treatment.
Time frame: 7 days
Changes of biomarker (MMP-9)
Evaluation of the change in MMP-9 on Day 7 of the treatment.
Time frame: 7 days
Changes of biomarker (S-100B)
Evaluation of the change in S-100B on Day 7 of the treatment.
Time frame: 7 days
Changes of biomarker (NSE)
Evaluation of the change in NSE on Day 7 of the treatment.
Time frame: 7 days
The proportion of the patients with Severity Adverse Events within 7 days of the treatment.
Severity Adverse Events
Time frame: 7 days
Changes in toxicology index including mercury and arsenic on Day 7 of the treatment.
toxicology index
Time frame: 7 days
The proportion of the patients with Adverse Events within 7 and 90 days of the treatment.
Adverse Events
Time frame: 7 days, 90 days
The proportion of the patients with All-cause mortality within 7 and 90 days of the treatment.
All-cause mortality
Time frame: 7 days, 90 days
The proportion of the patients with Combined vascular events within 7 and 90 days of the treatment.
Combined vascular events
Time frame: 7 days, 90 days
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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