Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial.

Shengde LI; Anxin WANG; Lin SHI; Qin LIU; Xiaoling GUO; Kun LIU; Xiaoli WANG; Jie LI; Jianming ZHU; Qiuyi WU; Qingcheng YANG; Xianbo ZHUANG; Hui YOU; Feng FENG; Yishan LUO; Huiling LI; Jun NI; Bin PENG

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Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial.

Author: Shengde LI ¹ ; Anxin WANG ² ; Lin SHI ³ ; Qin LIU ⁴ ; Xiaoling GUO ⁵ ; Kun LIU ⁶ ; Xiaoli WANG ⁷ ; Jie LI ⁸ ; Jianming ZHU ⁹ ; Qiuyi WU ¹⁰ ; Qingcheng YANG ¹¹ ; Xianbo ZHUANG ¹² ; Hui YOU ¹³ ; Feng FENG ¹³ ; Yishan LUO ³ ; Huiling LI ¹⁴ ; Jun NI ¹ ; Bin PENG ¹
Author Information

1. Department of Neurology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100730, China.
2. Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.
3. BrainNow Research Institute, Shenzhen, Guangdong 518000, China.
4. Department of Neurology, The Second People's Hospital of Yibin, Yibin, Sichuan 644000, China.
5. Department of Neurology, The First Affiliated Hospital of Anhui University of Technology, Huainan, Anhui 232007, China.
6. Department of Neurology, Brain Hospital of Hunan Province (The Second People's Hospital of Hunan Province), Changsha, Hunan 410007, China.
7. Department of Neurology, Hengshui People's Hospital, Hengshui, Hebei 053000, China.
8. Department of Neurology, The First People's Hospital of Yibin, Yibin, Sichuan 644000, China.
9. Department of Neurology, The First People's Hospital of Changde City, Changde, Hunan 415000, China.
10. Department of Neurology, The First People's Hospital of Zhangjiagang City, Suzhou, Jiangsu 215600, China.
11. Department of Neurology, The People's Hospital of Anyang City, Anyang, Henan 455000, China.
12. Department of Neurology, Liaocheng People's Hospital, Liaocheng, Shandong 252000, China.
13. Department of Radiology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100730, China.
14. Department of Occupational Medicine and Toxicologym, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
Publication Type:Randomized Controlled Trial
Keywords: Acute ischemic stroke; Angong Niuhuang Pill; Cerebral edema; Cerebral infarct; Pharmacology
MeSH: Aged; Female; Humans; Male; Middle Aged; Double-Blind Method; Drugs, Chinese Herbal/adverse effects*; Ischemic Stroke/drug therapy*; Pilot Projects; Stroke/drug therapy*; Treatment Outcome
From: Chinese Medical Journal 2025;138(5):579-588
CountryChina
Language:English
Abstract: BACKGROUND:Preclinical studies have indicated that Angong Niuhuang Pills (ANP) reduce cerebral infarct and edema volumes. This study aimed to investigate whether ANP safely reduces cerebral infarct and edema volumes in patients with moderate to severe acute ischemic stroke.
METHODS:This randomized, double-blind, placebo-controlled pilot trial included patients with acute ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores ranging from 10 to 20 in 17 centers in China between April 2021 and July 2022. Patients were allocated within 36 h after onset via block randomization to receive ANP or placebo (3 g/day for 5 days). The primary outcomes were changes in cerebral infarct and edema volumes after 14 days of treatment. The primary safety outcome was severe adverse events (SAEs) for 90 days.
RESULTS:There were 57 and 60 patients finally included in the ANP and placebo groups, respectively for modified intention-to-treat analysis. The median age was 66.0 years, and the median NIHSS score at baseline was 12.0. The changes in cerebral infarct volume at day 14 were 0.3 mL and 0.4 mL in the ANP and placebo groups, respectively (median difference: -7.1 mL; interquartile range [IQR]: -18.3 to 2.3 mL, P = 0.30). The changes in cerebral edema volume of the ANP and placebo groups on day 14 were 11.4 mL and 4.0 mL, respectively ( median difference: 3.0 mL, IQR: -1.3 to 9.9 mL, P = 0.15). The rates of SAE within 90 days were similar in the ANP (3/57, 5%) and placebo (7/60, 12%) groups ( P = 0.36). Changes in serum mercury and arsenic concentrations were comparable. In patients with large artery atherosclerosis, ANP reduced the cerebral infarct volume at 14 days (median difference: -12.3 mL; IQR: -27.7 to -0.3 mL, P = 0.03).
CONCLUSIONS:ANP showed a similar safety profile to placebo and non-significant tendency to reduce cerebral infarct volume in patients with moderate-to-severe stroke. Further studies are warranted to assess the efficacy of ANP in reducing cerebral infarcts and improving clinical prognosis.
TRAIL REGISTRATION:Clinicaltrials.gov , No. NCT04475328.