研究疾病:
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脑小血管病
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研究疾病代码:
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Target disease:
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Small cerebral vascular disease
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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上市后药物
Post-marketing clinical trial
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研究目的:
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本研究旨在运用全面神经心理学量表评估与多模态神经影像技术, 在“血脉同治”理论的指导下, 对高血压动脉粥样硬化及脑小血
管病患者的认知功能、头颅 MRI 以及肢体动脉测量等相关指标进行评估; 随后,采用随机对照的方法,将入组患者分为药物干预组和对照组, 采用中药血塞通软胶囊干预 24 周后, 比较入组前后两组患者认知功能、头颅 MRI 以及肢体动脉测量等相关指标的变化。
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Objectives of Study:
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This study aims to use comprehensive neuropsychological scale evaluation and multimodal neuroimaging technology, under the guidance of the "blood blood treatment" theory, to evaluate the cognitive function, head MRI, limb artery measurement and other related indicators in patients with hypertension atherosclerosis and small cerebral vascular disease. Subsequently, the enrolled patients were divided into drug intervention group and control group by randomized control method. After 24 weeks of intervention with Xuesaitong soft capsule, the changes of cognitive function, head MRI, limb artery measurement and other related indicators of the two groups were compared before and after inclusion.
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药物成份或治疗方案详述:
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经国家药品监督管理局官网查询,血塞通软胶囊(每粒含三七总皂苷60mg)的生产厂家昆明华润圣火药业有限公司已获得包含中药前处理和提取、软胶囊剂的良好操作规范(good manufacturing practices,GMP)认证, 最新发证日期为2019年4月22日,有效期五年,厂家严格按照《药品生产质量管理规范》进行药品生产,建立了完善的质量管理体系。血塞通软胶囊(每粒含三七总皂苷60mg)执行国家药品监督管理局国家药品标准[WS3-182(Z-25)-2002(Z)]。本品每粒(每粒含三七总皂苷60mg)含人参皂苷Rb1不得少于16.0mg、含人参皂苷Rg1不得少于12.0mg、含三七皂苷R1不得少于3.0mg,且人参皂苷Rb1、人参皂苷Rg1和三七皂苷R1的总量不得少于32.0mg。昆明市食品药品检验所提供了最新药品检验报告,根据国家药品监督管理局国家药品标准[WS3-182(Z-25)-2002(Z)]对铝塑包装(批号:20190509)和瓶装(批号:20190417)的血塞通软胶囊(每粒含三七总皂苷60mg)进行抽样检验,结果均符合规定。
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Description for medicine or protocol of treatment in detail:
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According to the inquiry on the official website of the National Medical Products Administration, the manufacturer of Xuesaitong Soft capsule (each containing 60mg total saponins of Notoginseng), Kunming China Resources Shenghuo Pharmaceutical Co., LTD., has obtained the good manufacturing practices (GMP) certification including the pre-treatment and extraction of traditional Chinese medicine and soft capsules. The latest issuing date is April 22, 2019, valid for five years. The manufacturer manufactures drugs in strict accordance with the "Good Practice for Drug Production Quality Management", and has established a perfect quality management system. Xuesaitong soft capsule (each containing 60mg total saponins of notoginseng) is subject to the National Drug Standard of the State Medical Products Administration [WS3-182(Z-25)-2002(Z)]. This product contains no less than 16.0mg ginsenoside Rb1, no less than 12.0mg ginsenoside Rg1 and no less than 3.0mg notoginseng saponin R1 per grain (each grain contains 60mg notoginseng saponin), and the total amount of ginsenoside Rb1, ginsenoside Rg1 and notoginseng saponin R1 shall not be less than 32.0mg. Kunming Institute for Food and Drug Control provided the latest drug inspection report. According to the National Drug standard [WS3-182(Z-25)-2002(Z)] of the State Drug Administration, Xuesaitong soft capsule (each containing 60mg total saponin of Notoginseng) in aluminum plastic packaging (batch number :20190509) and bottle (batch number :20190417) was extracted The samples were tested and the results were in conformity with the regulations.
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纳入标准:
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①年龄 50-80 岁的门诊或住院患者以及社区老年居民,性别不限,教育程度≥6 年;
②符合西医诊断标准及中医诊断标准;
③无任何卒中病史与体征;
④愿意被随机分配到试验组和对照组;
⑤自愿参加试验并签署知情同意书。
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Inclusion criteria
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① Outpatient or inpatient patients aged 50-80 years old and elderly residents in the community, regardless of gender, education level ≥6 years;
② Meet the diagnostic criteria of Western medicine and Chinese medicine;
③ no history and signs of stroke;
④ Willing to be randomly assigned to the test group and the control group;
⑤ Volunteer to participate in the experiment and sign the informed consent.
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排除标准:
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①严重心、肝、肾功能不全患者;
②有其他精神、神经系统疾患以及恶性肿瘤患者;
③入选前三个月内参加过其他药物试验者;
④依从性差或生命垂危不能完成疗程者;
⑤近三个月内使用其他改善认知功能药物如 ChEIs 或其他精神类药物。
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Exclusion criteria:
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① Patients with severe heart, liver and kidney insufficiency;
② Patients with other mental and nervous system diseases and malignant tumors;
③ Participants who had participated in other drug trials within three months before enrollment;
④ Poor compliance or life-threatening can not complete the course of treatment;
⑤ Use of other cognitive-improving drugs such as ChEIs or other psychotropic drugs within the last three months.
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研究实施时间:
Study execute time:
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从From
2022-01-14
至To
2023-09-13
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征募观察对象时间:
Recruiting time:
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从From
2022-01-14
至To
2023-09-13
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