Lin Jian, Liu Xinghua, Lin Xi, Liu Nanyang, Pei Hui, Zhao Yichun, Yu Guran, Wang Wei, Chen Chuan, Hou Tingting, Li Xun, Lin Xingdong, Li Hao
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.
Department of Geriatrics, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, People's Republic of China.
Int J Gen Med. 2024 Dec 13;17:6153-6164. doi: 10.2147/IJGM.S485314. eCollection 2024.
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.
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.
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.
Chinese Clinical Trial Registry, Registration Number: ChiCTR2300072768. Registered on 25 June 2023. https://www.chictr.org.cn/showproj.html?proj=195457.
阿尔茨海默病是一种退行性疾病，会导致患者出现进行性记忆衰退，且在任何给定时刻整体认知能力显著下降。老年人口的增加导致阿尔茨海默病的患病率显著上升，该疾病的全球影响亦是如此。先前的研究已证明中西医结合治疗阿尔茨海默病具有显著的临床疗效。本试验的主要目的是评估参芎黄连解毒颗粒联合多奈哌齐治疗轻度至中度阿尔茨海默病患者的有效性和安全性。
这是一项多中心、实用性随机对照试验。共有386名符合条件的轻度至中度阿尔茨海默病患者将被随机分配，并平等进入试验组或对照组。将观察参芎黄连解毒颗粒联合多奈哌齐的有效性和安全性。主要结局是阿尔茨海默病评估量表认知分量表得分的变化。次要结局包括中医证候评分量表、简易精神状态检查表、临床痴呆评定量表和日常生活活动量表的评估。我们还将分析阿尔茨海默病的血液生物标志物、炎症指标、氧化应激指标和血液流变学指标。此外，将在治疗基线、12周后和24周后进行安全性评估。
这些研究结果将为参芎黄连解毒颗粒联合多奈哌齐治疗轻度至中度阿尔茨海默病患者的有效性和安全性提供可靠的临床证据。此外，本研究将支持中西医结合纳入阿尔茨海默病的主流治疗，推动多靶点策略。
中国临床试验注册中心，注册号：ChiCTR2300072768。于2023年6月25日注册。https://www.chictr.org.cn/showproj.html?proj=195457。
