A Phase 3 interventional study of AngongNiuhuang pill and Placebo of AngongNiuhuang pill in Acute Ischemic Stroke, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-11-07.
Sponsored by Peking Union Medical College Hospital · Phase 3, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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Exclusion Criteria:
Drugs: AngongNiuhuang pill. The other treatments will be 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 be 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 1 pill 1 times/day for 5-day.
This group will receive Placebo of AngongNiuhuang pill 1 pill 1 times/day for 5-day.
The other treatments according to guidelines for standard treatment of acute ischemic stroke.
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.
Time frame: 90days
Severity Adverse Event
The percentage of the Severity Adverse Events within the 90 days of the therapy.
Time frame: 90days
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.
Time frame: 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.
Time frame: 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.）
Time frame: 30 days, 90 days
Recurrent stroke, death and other vascular events
The quantity of patients who has recurrent stroke, death and other vascular events.
Time frame: 30 days, 90 days
Changes of biomarker (hs-CRP)
Evaluation of the change in (centralization blood sample determination).
Time frame: 7 days
Changes of biomarker (IL-10)
Evaluation of the change in IL-10 (centralization blood sample determination).
Time frame: 7days
Changes of biomarker (TNF-α)
Evaluation of the change in TNF-α level (centralization blood sample determination).
Time frame: 7days
Adverse Events
The percentage of the Adverse Events during the therapy.
Time frame: 7 days, 90 days
Severity Adverse Event
The percentage of the Severity Adverse Events during the therapy.
Time frame: 7days
Plan to share: No
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Peking Union Medical College Hospital