An interventional study of Angong Niuhuang Pill and Angong Niuhuang Pill Matching Placebo in Acute Ischemic Stroke, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of early administration of Angong Niuhuang Pill in patients with disabling acute ischemic stroke.
Approximately 1,200 eligible participants will be randomly assigned in a 1:1 ratio to receive Angong Niuhuang Pill or a matching placebo for 5 consecutive days. Eligible participants will be adults aged 18 to 80 years with imaging-confirmed acute ischemic stroke involving the anterior circulation, a baseline National Institutes of Health Stroke Scale (NIHSS) score of 10 to 19, symptom onset or last known well within 24 hours before randomization, and a pre-stroke modified Rankin Scale (mRS) score of 0 or 1.
The primary efficacy outcome is the proportion of participants achieving functional independence at 90 days after randomization, defined as an mRS score of 0 to 2. Secondary outcomes include excellent functional outcome, the distribution of mRS scores at 90 days, change in the Barthel Index, changes in NIHSS scores, neurological improvement, and symptomatic intracranial hemorrhage. Safety outcomes include serious adverse events, all-cause mortality, and changes in hepatic and renal laboratory parameters.
Acute ischemic stroke is a major cause of death and long-term disability worldwide. Patients presenting with moderate-to-severe neurological deficits remain at substantial risk of poor functional outcomes despite advances in reperfusion therapies and contemporary standard-of-care management. Early neurological protection and limitation of secondary brain injury may therefore represent an important therapeutic strategy in addition to reperfusion and other standard treatments.
Angong Niuhuang Pill is a traditional Chinese medicine preparation that has been used clinically for acute neurological disorders. Preclinical and pharmacological evidence suggests that ANP may exert neuroprotective effects through multiple biological pathways, including attenuation of neuroinflammation, reduction of oxidative stress, preservation of the blood-brain barrier, and mitigation of ischemia-reperfusion injury. These potentially complementary mechanisms may help limit secondary neuronal injury and promote neurological recovery after acute cerebral ischemia. However, the clinical efficacy and safety of early ANP administration in patients with disabling acute ischemic stroke remain insufficiently established, particularly in patients with moderate-to-severe neurological deficits treated within the early phase after stroke onset.
Eligible patients will be adults aged 18 to 80 years with imaging-confirmed acute ischemic stroke involving the anterior circulation, a baseline National Institutes of Health Stroke Scale (NIHSS) score of 10 to 19, symptom onset or last known well within 24 hours before randomization, and a prestroke modified Rankin Scale (mRS) score of 0 to 1. Patients meeting all eligibility criteria will be centrally randomized in a 1:1 ratio using an interactive web response system with study-center stratification and block randomization.
Participants assigned to the intervention group will receive Angong Niuhuang Pill, 3 g once daily for 5 consecutive days, administered orally or through a nasogastric tube. Participants assigned to the control group will receive a matching placebo with the same dose, route of administration, and treatment duration. The placebo is designed to be similar in appearance, odor, taste, and packaging to the active treatment. Both groups will receive standard-of-care management for acute ischemic stroke according to applicable clinical guidelines and investigator judgment.
The primary objective is to determine whether early administration of ANP improves functional outcome at 90 days, as assessed by the proportion of participants achieving functional independence, defined as a modified Rankin Scale score of 0 to 2.
Secondary objectives include evaluation of excellent functional outcome (mRS 0-1) at 90 days, the distribution of mRS scores from 0 to 6 at 90 days, changes in the Barthel Index from baseline to day 90, changes in NIHSS from baseline to day 14 and day 7, the proportion of participants with a decrease in NIHSS score of at least 4 points by day 14, and the incidence of symptomatic intracranial hemorrhage within 7 days according to the European Cooperative Acute Stroke Study III (ECASS III) definition.
Safety will be assessed throughout the 90-day follow-up period, including serious adverse events, all-cause mortality, and changes in alanine aminotransferase, aspartate aminotransferase, and serum creatinine from baseline to day 7.
The study will enroll approximately 1,200 participants across multiple clinical centers in China. The treatment period is 5 days, and participants will be followed for 90 days after randomization. The study is designed to provide robust evidence regarding the efficacy and safety of early ANP administration as an adjunctive treatment for patients with disabling acute ischemic stroke.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Xuanwu Hospital, Beijing is the lead sponsor of 357 studies on the registry; 226 are open to participants now.
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Exclusion Criteria:
Drug: Angong Niuhuang Pill
Drug: Angong Niuhuang Pill Matching Placebo
Participants will receive Angong Niuhuang Pill at a dose of 1 pill (3 g) once daily for 5 consecutive days. The study medication will be administered orally or through a nasogastric tube.
Participants will receive a matching placebo at a dose of 1 pill (3 g) once daily for 5 consecutive days. The matching placebo is manufactured to resemble Angong Niuhuang Pill in appearance, odor, taste, dosage form, and packaging. The placebo contains 5% Angong Niuhuang Pill and no other medicinal ingredients. The study medication will be administered orally or through a nasogastric tube.
Functional Independence at 90 Days
The proportion of participants achieving functional independence at 90 days after randomization, defined as a modified Rankin Scale (mRS) score of 0 to 2. The mRS ranges from 0 to 6, with higher scores indicating greater disability.
Time frame: 90 ± 7 days after randomization
Excellent Functional Outcome at 90 Days
The proportion of participants achieving an excellent functional outcome at 90 days after randomization, defined as a modified Rankin Scale (mRS) score of 0 to 1.
Time frame: 90 ± 7 days after randomization
Distribution of Modified Rankin Scale Scores at 90 Days
The distribution of modified Rankin Scale (mRS) scores from 0 to 6 at 90 days after randomization. Higher scores indicate greater disability.
Time frame: 90 ± 7 days after randomization
Change in Barthel Index From Baseline to Day 90
The change in Barthel Index score from baseline to 90 days after randomization.
Time frame: Baseline to 90 ± 7 days after randomization
Change in NIHSS Score From Baseline to Day 14
The change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to day 14 after randomization. The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment.
Time frame: Baseline to day 14 ± 3 after randomization
Neurological Improvement at Day 14
The proportion of participants with neurological improvement at day 14 after randomization, defined as a reduction in NIHSS score of at least 4 points from baseline.
Time frame: Day 14 ± 3 after randomization
Change in NIHSS Score From Baseline to Day 7
The change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to day 7 after randomization.The total NIHSS score ranges from 0 to 42, where higher scores represent greater neurological impairment (worse outcome). A decrease in score indicates improvement.
Time frame: Baseline to day 7 after randomization
Symptomatic Intracranial Hemorrhage Within 7 Days
The proportion of participants experiencing symptomatic intracranial hemorrhage within 7 days after randomization, defined according to the European Cooperative Acute Stroke Study III (ECASS III) criteria.
Time frame: Within 7 days after randomization
Serious Adverse Events Within 90 Days
The proportion of participants experiencing at least one serious adverse event from randomization through day 90.
Time frame: From randomization through day 90 ± 7
All-Cause Mortality Within 90 Days
The proportion of participants who die from any cause within 90 days after randomization.
Time frame: Within 90 ± 7 days after randomization
Change in Serum Alanine Aminotransferase From Baseline to Day 7
The change in serum alanine aminotransferase (ALT) concentration from baseline to day 7 after randomization.
Time frame: Baseline to day 7 after randomization
Change in Serum Aspartate Aminotransferase From Baseline to Day 7
The change in serum aspartate aminotransferase (AST) concentration from baseline to day 7 after randomization.
Time frame: Baseline to day 7 after randomization
Change in Creatinine Clearance From Baseline to Day 7
The change in creatinine clearance from baseline to day 7 after randomization.
Time frame: Baseline to day 7 after randomization
Start is estimated for Oct 2026; primary completion for Jul 2027, 9 months later.
Of 569 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 9 months is below that.
Counting every sponsor, half of 652 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Angong Niuhuang Pill