Efficacy and safety of YQFM (YiQiFuMai lyophilized injection) on acute ischemic stroke (FAST): rationale and design for a randomized, double-blind, placebo-controlled trial
Abstract Background Low blood pressure at acute ischemic stroke onset is associated with both short- and long-term adverse outcomes. Studies have shown that YQFM (YiQiFuMai lyophilized injection) can ameliorate neurological deficits in ischemic stroke.However, all of these studies are all small-samp...
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| Language: | English |
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BMC
2025-07-01
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| Series: | BMC Complementary Medicine and Therapies |
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| Online Access: | https://doi.org/10.1186/s12906-025-05036-0 |
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| author | Yingzhi Xu Li Sun Zhaoyou Meng Xinxing Lai Dayong Ma Yuqiu An Boxuan Du Qiaosheng Ren Ying Gao Kegang Cao |
| author_facet | Yingzhi Xu Li Sun Zhaoyou Meng Xinxing Lai Dayong Ma Yuqiu An Boxuan Du Qiaosheng Ren Ying Gao Kegang Cao |
| author_sort | Yingzhi Xu |
| collection | DOAJ |
| description | Abstract Background Low blood pressure at acute ischemic stroke onset is associated with both short- and long-term adverse outcomes. Studies have shown that YQFM (YiQiFuMai lyophilized injection) can ameliorate neurological deficits in ischemic stroke.However, all of these studies are all small-sample clinical observations lacking rigorous study design for AIS with inappropriate blood pressure. Aims To describe the design of the YQFM aimed at reducing the disability rate in AIS patients with inappropriate blood pressure. Methods This trial is a prospective, multicenter, randomized, double-blind, placebo-controlled, superiority trial aimed at evaluating the efficacy and safety of YQFM in reducing the disability rate in patients with acute hypoperfusion stroke within 90 days. We will recruit 480 patients with AIS within 48 h of symptom onset from 24 hospitals, who have large atherosclerosis, systolic pressure ≤ 155 mmHg, and an NIHSS score of 4–18. Eligible patients will be randomly assigned to receive either YQFM or 0.9% NaCl injection once daily for 10 days and will be followed up until the 90th day after stroke onset.The primary outcome will be the proportion of patients with mRS ≤ 2 at 90 days after patient recruitment. Secondary outcomes will include the proportion of early neurological deterioration at 7 days, patient self-reported outcomes and the syndrome score at 10 days, MMSE scale and BI scale at 90 days.During the trial, adverse events will be recorded. These data will be analyzed according to the predetermined statistical analysis plan. Conclusion This study is the first randomized controlled double-blind trial to evaluate the efficacy and safety of YQFM in patients with AIS. This trial will provide evidence-based data for YQFM application in AIS with inappropriate blood pressure. Clinical trial registration ChiCTR2300074125 was registered on 31 July, 2023. For more information, please visit Clinical Trials.gov at https://www.chictr.org.cn/showproj.html?Proj=200686 . Graphical Abstract |
| format | Article |
| id | doaj-art-3338c1a140dc4e479b4995a00ec208a5 |
| institution | Kabale University |
| issn | 2662-7671 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Complementary Medicine and Therapies |
| spelling | doaj-art-3338c1a140dc4e479b4995a00ec208a52025-08-20T04:01:47ZengBMCBMC Complementary Medicine and Therapies2662-76712025-07-0125111210.1186/s12906-025-05036-0Efficacy and safety of YQFM (YiQiFuMai lyophilized injection) on acute ischemic stroke (FAST): rationale and design for a randomized, double-blind, placebo-controlled trialYingzhi Xu0Li Sun1Zhaoyou Meng2Xinxing Lai3Dayong Ma4Yuqiu An5Boxuan Du6Qiaosheng Ren7Ying Gao8Kegang Cao9Dongzhimen Hospital, Beijing University of Chinese MedicineDepartment of Neurology, The First Hospital of Jilin UniversityXinqiao Hospital, Army Medical UniversityDongzhimen Hospital, Beijing University of Chinese MedicineDongzhimen Hospital, Beijing University of Chinese MedicineDongzhimen Hospital, Beijing University of Chinese MedicineDongzhimen Hospital, Beijing University of Chinese MedicineDongzhimen Hospital, Beijing University of Chinese MedicineDongzhimen Hospital, Beijing University of Chinese MedicineDongzhimen Hospital, Beijing University of Chinese MedicineAbstract Background Low blood pressure at acute ischemic stroke onset is associated with both short- and long-term adverse outcomes. Studies have shown that YQFM (YiQiFuMai lyophilized injection) can ameliorate neurological deficits in ischemic stroke.However, all of these studies are all small-sample clinical observations lacking rigorous study design for AIS with inappropriate blood pressure. Aims To describe the design of the YQFM aimed at reducing the disability rate in AIS patients with inappropriate blood pressure. Methods This trial is a prospective, multicenter, randomized, double-blind, placebo-controlled, superiority trial aimed at evaluating the efficacy and safety of YQFM in reducing the disability rate in patients with acute hypoperfusion stroke within 90 days. We will recruit 480 patients with AIS within 48 h of symptom onset from 24 hospitals, who have large atherosclerosis, systolic pressure ≤ 155 mmHg, and an NIHSS score of 4–18. Eligible patients will be randomly assigned to receive either YQFM or 0.9% NaCl injection once daily for 10 days and will be followed up until the 90th day after stroke onset.The primary outcome will be the proportion of patients with mRS ≤ 2 at 90 days after patient recruitment. Secondary outcomes will include the proportion of early neurological deterioration at 7 days, patient self-reported outcomes and the syndrome score at 10 days, MMSE scale and BI scale at 90 days.During the trial, adverse events will be recorded. These data will be analyzed according to the predetermined statistical analysis plan. Conclusion This study is the first randomized controlled double-blind trial to evaluate the efficacy and safety of YQFM in patients with AIS. This trial will provide evidence-based data for YQFM application in AIS with inappropriate blood pressure. Clinical trial registration ChiCTR2300074125 was registered on 31 July, 2023. For more information, please visit Clinical Trials.gov at https://www.chictr.org.cn/showproj.html?Proj=200686 . Graphical Abstracthttps://doi.org/10.1186/s12906-025-05036-0Acute ischemic strokeYiQiFuMai lyophilized injectionEfficacySafetyRandomized controlled trial |
| spellingShingle | Yingzhi Xu Li Sun Zhaoyou Meng Xinxing Lai Dayong Ma Yuqiu An Boxuan Du Qiaosheng Ren Ying Gao Kegang Cao Efficacy and safety of YQFM (YiQiFuMai lyophilized injection) on acute ischemic stroke (FAST): rationale and design for a randomized, double-blind, placebo-controlled trial BMC Complementary Medicine and Therapies Acute ischemic stroke YiQiFuMai lyophilized injection Efficacy Safety Randomized controlled trial |
| title | Efficacy and safety of YQFM (YiQiFuMai lyophilized injection) on acute ischemic stroke (FAST): rationale and design for a randomized, double-blind, placebo-controlled trial |
| title_full | Efficacy and safety of YQFM (YiQiFuMai lyophilized injection) on acute ischemic stroke (FAST): rationale and design for a randomized, double-blind, placebo-controlled trial |
| title_fullStr | Efficacy and safety of YQFM (YiQiFuMai lyophilized injection) on acute ischemic stroke (FAST): rationale and design for a randomized, double-blind, placebo-controlled trial |
| title_full_unstemmed | Efficacy and safety of YQFM (YiQiFuMai lyophilized injection) on acute ischemic stroke (FAST): rationale and design for a randomized, double-blind, placebo-controlled trial |
| title_short | Efficacy and safety of YQFM (YiQiFuMai lyophilized injection) on acute ischemic stroke (FAST): rationale and design for a randomized, double-blind, placebo-controlled trial |
| title_sort | efficacy and safety of yqfm yiqifumai lyophilized injection on acute ischemic stroke fast rationale and design for a randomized double blind placebo controlled trial |
| topic | Acute ischemic stroke YiQiFuMai lyophilized injection Efficacy Safety Randomized controlled trial |
| url | https://doi.org/10.1186/s12906-025-05036-0 |
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