Trial reportChinese journal of integrative medicine2025
Effect of Huatuo Zaizao Pill on Neurological Function and Limb Motor Recovery in Ischemic Stroke Patients During Convalescence: An Open-Labelled, Randomized Controlled Trial.
Trial report in Chinese journal of integrative medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04910256 (The Effect of Huatuo Zaizao Pill on Neurological Function and Motor Recovery in Ischemic Stroke Patients During the Recovery Stage), which is not on this map. Not yet cited in PubMed.
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The Effect of Huatuo Zaizao Pill on Neurological Function and Motor Recovery in Ischemic Stroke Patients During the Recovery Stage: a Open-labelled, Randomized Controlled Trial
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5 authors.
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Abstract
objectiveTo evaluate the effects of Chinese patent medicine Huatuo Zaizao Pill (HTZZ) on neurological function and limb motor in ischemic stroke (IS) patients during convalescence.
methodsThis is a prospective, open-labelled, randomized controlled trial. Patients with IS were recruited from the Neurology Department of Xiyuan Hospital of China Academy of Chinese Medical Sciences from May 2021 to June 2023. Eligible participants were randomly assigned to the HTZZ (40 cases) or control group (40 cases) at a ratio of 1:1. The HTZZ group was treated with oral HTZZ (8 g, thrice daily) combined with conventional treatment, while the control group received only conventional treatment. The treatment duration was 12 weeks. The primary outcome was the change in Modified Ashworth Scale (MAS) score from baseline to week 6 and 12. Secondary outcomes included changes in scores of National Institute of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment (FM), and Barthel Index (BI) from baseline to week 6 and 12, as well as lipid indices after 12 weeks. All adverse events (AEs) were recorded and liver and kidney indices were evaluated.
resultsA total of 72 patients completed the study (38 in the HTZZ group and 34 in the control group). Compared with the control group, the HTZZ group demonstrated significant improvements in MAS, NIHSS, FM, and BI scores following 6 and 12 weeks of treatment in both intent-to-treat and per-protocol analyses (all P<0.05). No significant differences were noted between groups in lipid indices, AEs, and liver and kidney dysfunction after 12 weeks (P>0.05).
conclusionsHTZZ alleviated spasticity and enhanced neurological function and prognosis of IS patients during convalescence. However, further evaluation of HTZZ's effect on IS outcomes is warranted in clinical trials with larger sample sizes and extended observation periods. (Trial registration No. NCT04910256).
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