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.

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.