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The Clinical Trial of Chinese Herbal Medicine (SaiLuoTong) Capsule

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研究单位: [1]Shineway Pharmaceutical Co.,Ltd [2]Xuan Wu Hospital of Capital Medical University [3]Peking University Shougang Hospital,Beijing, Beijing, China, 100144 [4]Xiyuan Hospital,Beijing, Beijing, China [5]Affiliated Hospital of Hebei University,Baoding, Hebei, China [6]Affiliated Hospital of Chengde Medical College,Chengde, Hebei, China, 067000 [7]Handan First Hospital,Handan, Hebei, China, 056000 [8]Hebei Central Hospital of petrochina,Langfang, Hebei, China, 065000 [9]The First Hospital of Hebei Medical University,Shijiazhuang, Hebei, China, 050000 [10]The Third Hospital of Hebei Medical University,Shijiazhuang, Hebei, China, 050051 [11]The Fourth Hospital of Medical University,Harbin, Hei Longjiang, China [12]The First People's Hospital of Luoyang,Luoyang, Henan, China, 471000 [13]The First affiliated Hospital of Nanyang Medical college,Nanyang, Henan, China, 473000 [14]Nanyang Second People's Hospital,Nanyang, Henan, China, 473003 [15]The First Hospital of Changsha,Changsha, Hunan, China, 41000 [16]Xiangya Boai Rehability Hospital,Changsha, Hunan, China [17]Yueyang Second People's Hospital,Yueyang, Hunan, China, 414000 [18]Baogang Hospital,Baotou, Inner Mongolia, China, 014000 [19]Inner Mongolia International Mongolian Hospital,Hohhot, Inner Mongolia, China [20]Taizhou Hospital of Chinese Medicine,Taizhou, Jiangsu, China, 225300 [21]Jiujiang University Clinical Medical College ▪ Jiujiang University Hospital,Jiujiang, Jiangxi, China, 332000 [22]The Fourth Affiliated Hospital of Nanchang University,Nanchang, Jiangxi, China, 330000 [23]Nanchang Hongdu Hospital of TCM,Nanchang, Jiangxi, China [24]Changzhi People's Hospital,Changzhi, Shanxi, China, 046000 [25]Jinzhong First People's Hospital,Jinzhong, Shanxi, China [26]Xianyang Hospital of Yan'an University,Xianyang, Shanxi, China, 712000 [27]Yuncheng Central Hospital,Yuncheng, Shanxi, China [28]The Second people's Hospital of Neijiang,Neijiang, Sichuan, China [29]Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin, Tianjin, China, 300250 [30]The Second Hospital of Xingjiang Medical University,Ürümqi, Xingjiang, China [31]The Central Hospital of Lishui City,Lishui, Zhejiang, China, 323000 [32]Wenzhou Hospital of Traditional Chinese Medicine,Wenzhou, Zhejiang, China, 325000

关键词: Vascular Dementia cognitive

研究目的:
As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial effects on learning and memory ability in animal models of vascular dementia (VaD). According to the result of the phase II study, the efficacy of SaiLuoTong capsule in the treatment of patients with VaD was better than that of placebo group and no difference in safety. So the study hypothesis is also that SaiLuoTong capsule will be effective in the treatment of patients with VaD and will be well tolerated. The purpose of the study is to confirm the efficacy and safety of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures include general cognitive function, executive function, daily living skills, and mental behavior changes of symptoms in VaD patients.

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