Trial reportFrontiers in medicine2026
Association of N-butylphthalide treatment with 1-year activities-of-daily-living recovery in convalescent ischemic stroke patients with chronic disease burden: a post-marketing real-world non-randomized controlled study.
Trial report in Frontiers in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
9 authors.
Funding
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Abstract
Background and objective: ADL recovery is essential for maintaining independence and reducing care burden after IS, particularly in patients with chronic vascular-metabolic disease burden. Although NBP has been studied for acute treatment, recurrence prevention, and cognitive protection, its association with ADL recovery in convalescent IS remains unclear. This study evaluated whether NBP treatment was associated with 1-year ADL recovery in a post-marketing real-world non-randomized controlled study. Methods: This was a post-marketing, real-world, prospective, non-randomized controlled study conducted in Jizhou District, Tianjin, China. Patients received either NBP plus basic treatment or basic treatment alone and were followed for 12 months. The primary outcome was change in BI score from baseline to 1 year. Secondary outcomes included change in mRS score, mRS >2, BI ≤ 60, and item-level BI changes. Chronic disease burden was defined as the cumulative number of hypertension, diabetes, hyperlipidemia, obesity, and coronary heart disease. Multivariable regression, subgroup analyses, IPTW analysis, and conservative death-imputation analysis were performed. This post-marketing, real-world, prospective, non-randomized controlled study was registered in the Chinese Clinical Trial Registry (ChiCTR2000039118). Results: Among 1,190 enrolled patients, 1,095 completed 1-year functional assessment, including 533 in the NBP group and 562 in the control group. Patients receiving NBP had slightly worse baseline mRS scores and a higher chronic disease burden than controls. At 1 year, the NBP group showed greater BI improvement than the control group (1.31 ± 13.99 vs. -1.11 ± 15.56; Conclusion: In this post-marketing real-world non-randomized controlled study, NBP treatment was associated with better 1-year ADL recovery in convalescent IS patients with chronic disease burden, mainly reflected by BI improvement and self-care or mobility-related gains rather than global disability change. These findings support ADL-centered assessment in long-term post-stroke care and suggest that functional recovery should be considered alongside recurrent event prevention and cognitive protection in aging stroke populations. Clinical Trial Registration: [ChiCTR2000039118]; http://www.chictr.org.cn.
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