研究单位：[1]Capital Medical University[2]Xinjiang Uygur Pharmaceutical Co., Ltd.[3]Hefei Second People's Hospital,Hefei,Anhui,China,230012[4]Lu'an Hospital of traditional Chinese Medicine,Lu'an,Anhui,China,237005[5]Xuanwu Hospital of Capital Medical University,Beijing,Beijing,China,100053[6]Oriental Hospital of Beijing University of traditional Chinese Medicine,Beijing,Beijing,China,100078[7]The First Affiliated Hospital of Chongqing Medical University,Chongqing,Chongqing,China,400042[8]Sun Yat Sen Memorial Hospital of Sun Yat sen University,Guangzhou,Guangdong,China,510289[9]Affiliated Hospital of Chengde Medical College,Chengde,Hebei,China,067020[10]Daqing People's Hospital,Daqing,Heilongjiang,China,163711[11]Luoyang First Hospital of traditional Chinese Medicine,Luoyang,Henan,China,471099[12]Jiangsu Hospital of traditional Chinese Medicine,Nanyang,Jiangsu,China,210004[13]Taizhou Hospital of traditional Chinese Medicine,Taizhou,Jiangsu,China,225399[14]Wuxi Second People's Hospital,Wuxi,Jiangsu,China,214001[15]Yangzhou First People's Hospital,Yangzhou,Jiangsu,China,225007[16]Fourth Hospital of Jilin University,Changchun,Jilin,China,130013[17]PLA Northern Theater Air Force Hospital,Shenyang,Liaoning,China,110092[18]Huashan Hospital Affiliated to Fudan University,Shanghai,Shanghai,China,200040[19]The First Hospital of Shanxi Medical University,Taiyuan,Shanxi,China,030001[20]Shanxi Hospital of traditional Chinese Medicine,Xi'an,Shanxi,China,710003[21]Xi'an High Tech Hospital,Xi'an,Shanxi,China,710077[22]Xidian Group Hospital,Xi'an,Shanxi,China,710077[23]Affiliated Hospital of Southwest Medical University,Luzhou,Sichuan,China,646000[24]The Fifth Affiliated Hospital of Xinjiang Medical University,Ürümqi,Xinjiang Uygur Autonomous Region,China,830011[25]Zhejiang Hospital,Hangzhou,Zhejiang,China,310013
In clinical trials of preclinical pharmacodynamic studies, Flos Gossypii Flavonoids Tablet has been proved to significantly improve the learning and memory ability of Alzheimer's disease model. Phase I clinical tolerance test is to observe the human body's tolerance to Flos Gossypii Flavonoids Tablet, and provide a basis for the formulation of safe and reasonable dosing regimens for phase II clinical trials. Therefore, a Phase II clinical trial is now being conducted to explore the efficacy and safety of the Flos Gossypii Flavonoids Tablet in the treatment of mild to moderate Alzheimer's disease (marinus sea deficiency/brain collateral stasis syndrome). In this study, the researchers will use a multicenter, randomized, double-blind, placebo-controlled parallel method to recruit AD patients to confirm the efficacy and safety of Flos Gossypii Flavonoids Tablet. Confirmation of drug efficacy will be observed through changes in AD patients' general cognitive and different cognitive domain functions, daily living activities, and symptom severities.
