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Abstract：
BACKGROUND: Hypertension in the elderly with cognitive impairment has been one of the global health issues. Mild cognitive impairment (MCI) is the state of transition between the normal aging process and cognitive changes of unformed dementia. Diagnosis and treatment of MCI are the keys to prevent dementia, and hypertension is one of the important influencing factors of MCI. Our preclinical experiment found that Yizhi Qingxin Decoction (YQD) could effectively reduce the blood pressure of spontaneously hypertensive rats (SHR), improve their spatial learning and memory abilities in Morris water maze, and play a neuroprotective role. The objective is to estimate the safety and efficacy of YQD (capsules) in the treatment of hypertension in the elderly with MCI (deficiency of kidney essence syndrome) through this study.
METHODS: According to the random number generated by the block random method, 100 participants will be randomly and equally divided into the treatment group (YQD) or the control group (Ginkgo biloba extract tablets). The conversion rate of dementia will be used as the main evaluating indicator by the CDR scale. The MoCA scale, MMSE scale, ADCS-MCI-ADL-24 scale, CGIC-KDS scale, and 24-h ambulatory blood pressure will be used as the secondary evaluating indicator. Safety will be evaluated based on specific manifestations of adverse reactions and the incidence of adverse events.
OBJECTIVE: The objective is to estimate the curative effect of YQD (capsules) on hypertension in the elderly with MCI (deficiency of kidney essence syndrome), and to evaluate the safety of its clinical application.
BACKGROUND: Chinese Clinical Trial Registry (ICTRP member): ChiCTR2000030292.
METHODS: According to the random number generated by the block random method, 100 participants will be randomly and equally divided into the treatment group (YQD) or the control group (Ginkgo biloba extract tablets). The conversion rate of dementia will be used as the main evaluating indicator by the CDR scale. The MoCA scale, MMSE scale, ADCS-MCI-ADL-24 scale, CGIC-KDS scale, and 24-h ambulatory blood pressure will be used as the secondary evaluating indicator. Safety will be evaluated based on specific manifestations of adverse reactions and the incidence of adverse events.
OBJECTIVE: The objective is to estimate the curative effect of YQD (capsules) on hypertension in the elderly with MCI (deficiency of kidney essence syndrome), and to evaluate the safety of its clinical application.
BACKGROUND: Chinese Clinical Trial Registry (ICTRP member): ChiCTR2000030292.
摘要：
背景：老年高血压伴认知障碍已成为全球健康问题之一。轻度认知障碍(MCI)是指正常衰老过程与未成形痴呆认知改变之间的过渡状态。MCI的诊断和治疗是预防痴呆的关键,高血压是MCI的重要影响因素之一。临床前实验发现益智清心汤(YQD)能有效降低自发性高血压大鼠(SHR)的血压,提高他们在莫里斯水迷宫中的空间学习和记忆能力，发挥神经保护作用.目的是通过本研究评估YQD（胶囊）治疗老年MCI（肾精虚证）高血压的安全性和有效性。
方法：根据块随机方法生成的随机数，将100名参与者随机平均分为治疗组（YQD）或对照组（银杏叶提取物片）。CDR量表将以痴呆的转化率作为主要评价指标。MoCA量表,MMSE量表,ADCS-MCI-ADL-24量表,CGIC-KDS量表,24小时动态血压将作为次要评估指标。安全性将根据不良反应的具体表现和不良事件的发生率进行评估。
目的：目的是评价益气胶囊对老年高血压伴MCI(肾精不足证)患者的疗效。并评价其临床应用的安全性。
背景：中国临床试验注册中心（ICTRP成员）：ChiCTR2000030292。
方法：根据块随机方法生成的随机数，将100名参与者随机平均分为治疗组（YQD）或对照组（银杏叶提取物片）。CDR量表将以痴呆的转化率作为主要评价指标。MoCA量表,MMSE量表,ADCS-MCI-ADL-24量表,CGIC-KDS量表,24小时动态血压将作为次要评估指标。安全性将根据不良反应的具体表现和不良事件的发生率进行评估。
目的：目的是评价益气胶囊对老年高血压伴MCI(肾精不足证)患者的疗效。并评价其临床应用的安全性。
背景：中国临床试验注册中心（ICTRP成员）：ChiCTR2000030292。
