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

Jian Lin,1 Xinghua Liu,1 Xi Lin,1 Nanyang Liu,2 Hui Pei,2 Yichun Zhao,3 Guran Yu,4 Wei Wang,5 Chuan Chen,6 Tingting Hou,7 Xun Li,8 Xingdong Lin,1 Hao Li9 1Department of Encephalopathy, The Third Affiliated Hospital of Guangzhou University of Chinese Medicine: Guangzhou University of Chinese Medicine Third Clinical Medical College, Guangzhou, 510378, People’s Republic of China; 2Department of Geriatrics, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, People’s Republic of China; 3Department of Neurology, Wuxi Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine, Wuxi, 214045, People’s Republic of China; 4Department of Neurology, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, People’s Republic of China; 5Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, 100053, People’s Republic of China; 6Shanghai Geriatric Institute of Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200031, People’s Republic of China; 7Department of Neurology, Shandong First Medical University Affiliated Provincial Hospital, Jinan, 250021, People’s Republic of China; 8Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, People’s Republic of China; 9Department of Geriatrics, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, 100102, People’s Republic of ChinaCorrespondence: Xingdong Lin, Department of Encephalopathy, The Third Affiliated Hospital of Guangzhou University of Chinese Medicine: Guangzhou University of Chinese Medicine Third Clinical Medical College, Guangzhou, 510378, People’s Republic of China, Email [email protected] Hao Li, Department of Geriatrics, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, 100102, People’s Republic of China, Email [email protected]: 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.Keywords: Alzheimer’s disease, Shenxiong Huanglian Detoxification Granule, Chinese medicine, study protocol