研究疾病:
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临界高血压
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研究疾病代码:
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Target disease:
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borderline hypertension
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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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II期临床试验
Phase II clinical trial
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研究目的:
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基于临界高血压的中医药复方—复元方,通过前瞻性多中心、随机、双盲、安慰剂平行对照临床试验,评价复元方对临界高血压人群的临床有效性、安全性。为临床提供复元方干预临界高血压人群的高级别循证医学证据,促进 “三结合” 审评体系指导下新产品产出和相关指南制定。
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Objectives of Study:
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Based on the traditional Chinese medicine compound of borderline hypertension, Fuyuan granule, through a prospective multicenter, randomized, double-blind, placebo-controlled clinical trial, the clinical efficacy and safety of Fuyuan granule on borderline hypertension population were evaluated. Provide high-level evidence-based medical evidence of Fuyuan granule's intervention in critically hypertensive populations for clinical use, and promote the production of new products and the formulation of relevant guidelines under the guidance of the "three-in-one" review system.
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药物成份或治疗方案详述:
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(1)干预方案的分组:试验组 120 例,给予健康宣教+复元方;对照组 120 例,给予健康宣教+安慰剂 (2)干预方案 ①健康宣教:包括健康教育、饮食营养管理、心理护理、运动推荐等。 ②复元方:由西苑医院制剂室统一进行生产,制成颗粒剂,1 包/次,2 次/ 日。③安慰剂:根据复元方的口感与色泽,由西苑医院制剂室统一提供。 ⑤应用基于手机 APP 网络云端大数据的中医智能化临界高血压管理平台, 受试对象可通过 APP 定期接受体质测评、心血管风险评估、心理测评等量表测 评,获得疾病相关宣教知识,掌握主动降低血压的方法,并接受一定的被试监督, 保证干预的有效实施。试验组每日打卡测血压+复元方;对照组每日打卡测血压 +复元方安慰剂。受试者在 APP 中的数据将上传云端,后期用作疗效评价及相 关分析。
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Description for medicine or protocol of treatment in detail:
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(1) Grouping of the intervention program: 120 cases in the Intervention group were given health education + Fuyuan granule; 120 cases in the control group were given health education + placebo (2) Intervention program ①Health education: including health education, diet and nutrition management, and psychological care , sports recommendations, etc. ②Fuyuan granule: It is uniformly produced by the preparation room of Xiyuan Hospital and made into granules, 1 pack/time, 2 times/day. ③Placebo: According to the taste and color of Fuyuan granule, it was provided by the preparation room of Xiyuan Hospital. ⑤Apply the TCM intelligent critical hypertension management platform based on mobile APP network cloud big data, subjects can regularly receive physical fitness assessment, cardiovascular risk assessment, psychological assessment and other scale assessments through the APP, obtain disease-related education knowledge, master the initiative Methods of lowering blood pressure and subject to certain supervision to ensure the effective implementation of the intervention. The experimental group was given daily check-in to measure blood pressure + Fuyuan granule; the control group was given daily check-in to measure blood pressure + Fuyuan granule placebo. The data of the subjects in the APP will be uploaded to the cloud, which will be used for efficacy evaluation and related analysis later.
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纳入标准:
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(1)年龄 18~65 周岁;(2)收缩压 120~139mmHg 和/或舒张压 80~89mmHg;(3)没有以西药或中药、针灸疗法控制血压(或已停止治疗方法 2 周); (4)愿意被随机分配到主被动干预技术组和对照组;(5)能够进行轻度到中度的运动;(6)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) Age 18 ~ 65 years old; (2) Systolic blood pressure 120 ~ 139mmHg and / or diastolic blood pressure 80 ~ 89mmHg; (3) The blood pressure was not controlled by western medicine, traditional Chinese medicine or acupuncture (or the treatment method was stopped for 2 weeks); (4) Willing to be randomly assigned to active and passive intervention technology group and control group; (5) Able to perform mild to moderate exercise; (6) Volunteer to participate in the trial and sign the informed consent form.
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排除标准:
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(1)继发性高血压;(2)孕妇和哺乳期妇女;(3)非优势臂围>50cm;(4)体重指数≥40.0kg/m2; (5)服用苯二氮卓类、抗精神病药物或口服糖皮质激素类药物(允许 3 个月内 稳定使用氟西汀、帕罗西汀、舍曲林、氟伏沙明、西酞普兰和艾司西酞普兰);(6)确诊冠心病;(7)入组肝肾功能提示:ALT、AST>2 倍正常值上限;Cr>2 倍正常值上限, eGFR<60mL/min 的慢性肾脏病(参考所在研究中心实验室检查正常值范围);(8)已知的自主神经病变;(如 Shy-Drager 综合征、直立性低血压、白大衣高血压); (9)酒精摄入量男性≥25g/天(约 65ml 北京二锅头),或≥140g/周;女性≥15g/ 天(约 33ml 北京二锅头),或≥80g/周;(10)合并恶性肿瘤、血液、消化、或其他系统严重或进行性疾病;(11)研究者认为不宜参加本临床试验者。
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Exclusion criteria:
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(1) Secondary hypertension; (2) Pregnant and lactating women; (3) Non dominant arm circumference > 50cm; (4) Body mass index ≥ 40.0kg/m2; (5) Taking benzodiazepines, antipsychotics or oral glucocorticoids (fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram and escitalopram are allowed to be used stably within 3 months); (6) Diagnose coronary heart disease; (7)ALT and AST > 2 times the upper limit of normal value; Chronic kidney disease with Cr > 2 times the upper limit of normal value and EGFR < 60ml/min (refer to the normal value range of laboratory examination in the research center) (8) Known autonomic neuropathy; (such as shy Drager syndrome, orthostatic hypotension, white coat hypertension); (9) Male alcohol intake ≥ 25g/ day (about 65ml Beijing Erguotou), or ≥ 140g/ week; Female ≥ 15g/ day (about 33ml Beijing Erguotou), or ≥ 80g/ week; (10) Complicated with malignant tumor, blood, digestive or other serious or progressive diseases; (11) The investigator believes that it is not appropriate to participate in this clinical trial.
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研究实施时间:
Study execute time:
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从From
2021-11-01
至To
2024-12-30
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征募观察对象时间:
Recruiting time:
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从From
2022-08-01
至To
2024-06-30
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