Effectiveness and Safety of Shenxiong Huanglian Detoxification Granule Combined with Donepezil for the Treatment of Alzheimer's Disease: Study Protocol for a Multicenter, Pragmatic, Randomized Controlled Clinical Trial
机构:[1]Guangzhou Univ Chinese Med, Affiliated Hosp 3, Clin Med Coll 3, Dept Encephalopathy, Guangzhou 510378, Peoples R China[2]China Acad Chinese Med Sci, Xiyuan Hosp, Dept Geriatr, Beijing 100091, Peoples R China[3]Nanjing Univ Chinese Med, Wuxi Tradit Chinese Med Hosp, Dept Neurol, Wuxi 214000, Jiangsu, Peoples R China[4]Nanjing Univ Chinese Med, Affiliated Hosp, Dept Neurol, Nanjing 210029, Peoples R China[5]Capital Med Univ, Xuanwu Hosp, Dept Neurol, Beijing 100053, Peoples R China首都医科大学宣武医院[6]Shanghai Univ Tradit Chinese Med, Shanghai Geriatr Inst Chinese Med, Shanghai 200031, Peoples R China[7]Shandong First Med Univ, Affiliated Prov Hosp, Dept Neurol, Jinan 250014, Peoples R China[8]Beijing Univ Chinese Med, Ctr Evidence Based Chinese Med, Beijing, Peoples R China[9]China Acad Chinese Med Sci, Wangjing Hosp, Dept Geriatr, Beijing 100102, Peoples R China
Background: Alzheimer's disease is a degenerative condition that causes patients to experience progressive memory decline and a significant decline in overall cognitive ability at any given moment. The increase in the elderly population has resulted in a notable surge in the prevalence of Alzheimer's disease, as has the global impact of the disease. Significant clinical efficacy of traditional Chinese medicine in combination with Western medicine for the treatment of Alzheimer's disease has been demonstrated in previous studies. The main purpose of this trial is to assess the effectiveness and safety of Shenxiong Huanglian Detoxification Granule combined with donepezil in individuals diagnosed with mild-to-moderate Alzheimer's disease. Methods: This is a multicenter, pragmatic, randomized controlled trial. A total of 386 eligible individuals with mild to moderate Alzheimer's disease will receive random assignment and equal access to the test or control group. The effectiveness and safety of Shenxiong Huanglian Detoxification Granule in combination with donepezil will be observed. The primary outcome is the alteration in scores acquired from the Alzheimer's Disease Assessment Scale-Cognitive Subscale. Secondary outcomes include the assessments of the Traditional Chinese Medicine Syndrome score scale, Mini-Mental State Examination, Clinical Dementia Rating, and Activity of Daily Living scale. We will also analyze blood biomarkers of Alzheimer's disease, inflammatory indicators, oxidative stress indicators, and hemorheology indicators. In addition, safety assessments will be conducted at baseline, after 12 weeks, and after 24 weeks of treatment. Discussion: These findings will offer reliable clinical evidence regarding the effectiveness and safety of Shenxiong Huanglian Detoxification Granule in combination with donepezil for treating patients with mild-to-moderate Alzheimer's disease. Additionally, this study will support the integration of traditional Chinese and Western medicine into mainstream treatment for Alzheimer's disease, promoting a multitarget strategy. Trial Registration: Chinese Clinical Trial Registry, Registration Number: ChiCTR2300072768. Registered on 25 June 2023. https:// www.chictr.org.cn/showproj.html?proj=195457.
基金:
National Key R&D Program of China [2022YFC3501400]
第一作者机构:[1]Guangzhou Univ Chinese Med, Affiliated Hosp 3, Clin Med Coll 3, Dept Encephalopathy, Guangzhou 510378, Peoples R China
通讯作者:
推荐引用方式(GB/T 7714):
Lin Jian,Liu Xinghua,Lin Xi,et al.Effectiveness and Safety of Shenxiong Huanglian Detoxification Granule Combined with Donepezil for the Treatment of Alzheimer's Disease: Study Protocol for a Multicenter, Pragmatic, Randomized Controlled Clinical Trial[J].INTERNATIONAL JOURNAL OF GENERAL MEDICINE.2024,17:6153-6164.doi:10.2147/IJGM.S485314.
APA:
Lin, Jian,Liu, Xinghua,Lin, Xi,Liu, Nanyang,Pei, Hui...&Li, Hao.(2024).Effectiveness and Safety of Shenxiong Huanglian Detoxification Granule Combined with Donepezil for the Treatment of Alzheimer's Disease: Study Protocol for a Multicenter, Pragmatic, Randomized Controlled Clinical Trial.INTERNATIONAL JOURNAL OF GENERAL MEDICINE,17,
MLA:
Lin, Jian,et al."Effectiveness and Safety of Shenxiong Huanglian Detoxification Granule Combined with Donepezil for the Treatment of Alzheimer's Disease: Study Protocol for a Multicenter, Pragmatic, Randomized Controlled Clinical Trial".INTERNATIONAL JOURNAL OF GENERAL MEDICINE 17.(2024):6153-6164