Efficacy of Yangyin Yiqi Huoxue Granule (å»é´çæ°æ´»è¡é¢ç²) in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial.

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Date: Nov. 2021
From: Chinese Journal of Integrative Medicine(Vol. 27, Issue 11)
Publisher: Springer
Document Type: Report
Length: 464 words

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Keywords: stroke; qi-yin deficiency and blood stasis syndrome; Chinese medicine; randomized controlled trial Abstract Objective To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule (å»é´çæ°æ´»è¡é¢ç², YYHG) in the treatment of ischemic stroke (IS) patients with qi-yin deficiency and blood stasis syndrome (QYDBSS), and to explore its effective dosage. Methods The total of 288 patients were randomly assigned to the YYHG high-dose, YYHG low-dose, positive control (administered Xiaoshuantong Granule, XSTG, æ¶æ éé¢ç²), or placebo control (administered inert granule) groups (72 cases per group) by software-drived competitive block randomization. The trial was conducted for a 28-day period, with a 180-day follow-up period. The primary outcome was the comprehensive curative evaluation, and secondary outcomes were the National Institute of Health Stroke Scale (NIHSS) score, Barthel activities of daily living (ADL) index score, the quality of life index (QLI) score, and the Chinese medicine syndrome (CMS) score. All analyses were done on an intention-to-treat basis. The clinical safety was also assessed. Results The total of 288 participants were recruited between June 1, 2008 and September 30, 2009, and 287 patients received intervention the treatment groups were well balanced at baseline. The comprehensive cure rates of YYHG high-dose, low-dose, positive and placebo control groups were 63.38%, 31.94%, 36.11% and 6.14%, respectively there was a statistical difference between the two groups (P Conclusion YYHG is safe and effective in the treatment of IS patients with QYDBSS. Author Affiliation: (1) Institute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, 310053, Hangzhou, China (2) Neurology Department, Xinhua Hospital of Zhejiang Province, 310005, Hangzhou, China (3) Neurology Department, Integrated Medicine Hospital of Jilin Province, 133001, Yanbian, Jilin Province, China (4) Chinese Medicine Department, the Second Affiliated Hospital of Zhejiang University School of Medicine, 310000, Hangzhou, China (c) whtong@126.com Article History: Registration Date: 04/19/2021 Accepted Date: 08/19/2019 Online Date: 04/21/2021 Byline: Yu Wang (1), Jie-hong Yang (1), Hai-tong Wan (corresponding author) (1, c), Yu He (1), Bin Xu (2), Chang-shan Ai (3), Hui-fen Zhou (1), Li Yu (1), Hao-fang Wan (1), Xiao-dong Bie (4)

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Gale Document Number: GALE|A681341746