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已发表论文
如意珍宝丸联合白脉软膏治疗急性缺血性脑卒中的多臂、随机、双盲、安慰剂对照临床研究
Authors Jiang Z, Qin X, Wu X, Wang Z, Wang X, He L, Cuomu M, Mei Z, Hou H, Song H, Song J
Received 1 June 2025
Accepted for publication 12 September 2025
Published 17 September 2025 Volume 2025:21 Pages 1359—1368
DOI https://doi.org/10.2147/TCRM.S536519
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Professor Garry Walsh
Ziying Jiang,1,* Xinzuo Qin,1,* Xiao Wu,1,* Zijian Wang,1 Xinyu Wang,1 Lingqian He,1 Mingji Cuomu,2 Zhinan Mei,3 Hongping Hou,4 Haiqing Song,1 Juexian Song1
1Department of Neurology, Xuanwu Hospital, Capital Medical University & National Center for Neurological Disorders, Beijing, People’s Republic of China; 2Postgraduate Department, the University of Tibetan Medicine in Lhasa, Lhasa, Tibet, People’s Republic of China; 3College of Plant Science and Technology, Huazhong Agricultural University, Wuhan, Hubei, People’s Republic of China; 4Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Haiqing Song, Email songhq@vip.sina.com Juexian Song, Email songjuexian@xwhosp.org
Background: Ruyi Zhenbao Pills (RZPs) and Baimai Ointment (BMO), prescribed Tibetan formulations, have been confirmed as having a neuroprotective role in animal and cell models of stroke. However, the effects of RZPs and BMO in individuals with acute ischemic stroke (AIS) remain unclear. This is the first multicenter, large-sample, controlled trial to evaluate the therapeutic potential of traditional Tibetan medicine—specifically the RZP and BMO—in the treatment of AIS, thereby extending ethno-pharmacological evidence into modern stroke care.
Methods: A multi-arm, randomized, double-blind, placebo controlled clinical trial was conducted at 21 hospitals in China between December 2020 and September 2022. The inclusion criteria are as follows: individuals diagnosed as AIS, 18 to 75 years of age and within 14 days of AIS onset. Subjects were randomly assigned in a 1:1:1:1 ratio to RZPs+BMO, RZPs, BMO, or placebo. The primary outcome was change of Fugl–Meyer assessment (FMA) score from baseline to day 90.
Results: Four hundred and twenty-three participants were recruited and randomly allocated to the RZPs+BMO group (n=108), RZPs group (n=108), BMO group (n=99), or placebo group (n=108). The change from baseline to D90 in FMA score was 31.22 (SD 16.64) with RZPs+BMO, 29.25 (15.92) with RZPs, 29.88 (15.42) with BMO, and 19.20 (14.38) with placebo (RZPs+BMO group versus placebo group, P< 0.001).
Conclusion: Among Chinese patients suffering from AIS, combined RZPs and BMO therapy improved significantly the primary outcome of 90-day motor functions compared with placebo with acceptable safety, indicating that RZPs and BMO might be an effective therapeutic strategy in patients with AIS.
Keywords: Ruyi Zhenbao pills, Baimai ointment, acute ischemic stroke, traditional Tibetan medicine, neuroprotective agents
1Department of Neurology, Xuanwu Hospital, Capital Medical University & National Center for Neurological Disorders, Beijing, People’s Republic of China; 2Postgraduate Department, the University of Tibetan Medicine in Lhasa, Lhasa, Tibet, People’s Republic of China; 3College of Plant Science and Technology, Huazhong Agricultural University, Wuhan, Hubei, People’s Republic of China; 4Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Haiqing Song, Email songhq@vip.sina.com Juexian Song, Email songjuexian@xwhosp.org
Background: Ruyi Zhenbao Pills (RZPs) and Baimai Ointment (BMO), prescribed Tibetan formulations, have been confirmed as having a neuroprotective role in animal and cell models of stroke. However, the effects of RZPs and BMO in individuals with acute ischemic stroke (AIS) remain unclear. This is the first multicenter, large-sample, controlled trial to evaluate the therapeutic potential of traditional Tibetan medicine—specifically the RZP and BMO—in the treatment of AIS, thereby extending ethno-pharmacological evidence into modern stroke care.
Methods: A multi-arm, randomized, double-blind, placebo controlled clinical trial was conducted at 21 hospitals in China between December 2020 and September 2022. The inclusion criteria are as follows: individuals diagnosed as AIS, 18 to 75 years of age and within 14 days of AIS onset. Subjects were randomly assigned in a 1:1:1:1 ratio to RZPs+BMO, RZPs, BMO, or placebo. The primary outcome was change of Fugl–Meyer assessment (FMA) score from baseline to day 90.
Results: Four hundred and twenty-three participants were recruited and randomly allocated to the RZPs+BMO group (n=108), RZPs group (n=108), BMO group (n=99), or placebo group (n=108). The change from baseline to D90 in FMA score was 31.22 (SD 16.64) with RZPs+BMO, 29.25 (15.92) with RZPs, 29.88 (15.42) with BMO, and 19.20 (14.38) with placebo (RZPs+BMO group versus placebo group, P< 0.001).
Conclusion: Among Chinese patients suffering from AIS, combined RZPs and BMO therapy improved significantly the primary outcome of 90-day motor functions compared with placebo with acceptable safety, indicating that RZPs and BMO might be an effective therapeutic strategy in patients with AIS.
Keywords: Ruyi Zhenbao pills, Baimai ointment, acute ischemic stroke, traditional Tibetan medicine, neuroprotective agents