研究疾病:
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高血压合并早期肾损害
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研究疾病代码:
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Target disease:
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Hypertension combined with early kidney damage
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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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探索性研究/预试验
Pilot clinical trial
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研究目的:
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观察平调颗粒干预治疗肝阳上亢型高血压早期肾损害患者前后的中医证侯积分、动态血压及早期肾损害指标,评价其有效性及安全性,以预测平调颗粒对高血压靶器官的保护作用,评价平调颗粒的临床疗效,为该药在临床应用与推广提供理论和临床依据。
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Objectives of Study:
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To observe the TCM evidence points, dynamic blood pressure and early kidney damage indexes before and after the intervention of Pingtiao granules in the treatment of patients with liver-yang-hyperactivity type hypertension with early kidney damage, evaluate its effectiveness and safety, in order to predict the protective effect of Pingtiao granules on the target organs of hypertension, evaluate the clinical efficacy of Pingtiao granules, and provide theoretical and clinical bases for the application and popularization of this drug in the clinic.
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药物成份或治疗方案详述:
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(1)对照组
1)按照《中国高血压患者教育指南》对受试者进行健康教育:指导戒烟、控制饮酒量、合理搭配膳食、保持一定的运动量、降体重保持在合理的范围之内、调节情志。
2)西医常规治疗:缬沙坦胶囊(澳美制药(海南)有限公司,国药准字H20030153,规格:每粒80mg),每日一粒。降压目标:BP<140/90 mmHg,随患者血压控制情况调整用药剂量。
3)出现其他情况,可予相应处理。
(2)实验组
实验组在对照组的基础上,加服平调颗粒(国家编码:J440106001770064,平调颗粒组成:天麻10g、钩藤10g、白芍10g、川牛膝10g、桑寄生10g、杜仲10g、茯苓10g。以上中药均采用广东一方制药厂生产的颗粒剂,由广东省第二中医院中药房提供),每次1袋,每日2次口服,分别在早晚各1次。
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Description for medicine or protocol of treatment in detail:
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(1) Control group
1) Health education for the subjects according to the "Chinese Hypertension Patient Education Guidelines": guidance on smoking cessation, controlling the amount of alcohol consumption, rationalizing diet, maintaining a certain amount of exercise, lowering body weight to keep it within a reasonable range, and regulating emotions.
2) Western medicine conventional treatment: valsartan capsule (Aumi Pharmaceuticals (Hainan) Co., Ltd, State Pharmaceutical License H20030153, specification: 80mg per capsule), one capsule per day. Antihypertensive target: BP<140/90 mmHg, adjust the dosage of medication with the patient's BP control.
3) Other conditions may be treated accordingly.
(2) Experimental group
On the basis of the control group, the experimental group was given Pingtiao granules (country code: J440106001770064, composition of Pingtiao granules: Tianma 10g, Crochet 10g, White peony 10g, Sichuan hyssop 10g, Sanghsang 10g, Cortex Eucommiae 10g, Poria 10g. The above traditional Chinese medicines were used in granules produced by Guangdong Fang Fang Pharmaceutical Factory, provided by the Chinese medicine pharmacy of the Second Guangdong Hospital of Traditional Chinese Medicine), 1 bag each time, orally twice a day, and the granules were used in the experimental group. Take 1 sachet each time, orally twice a day, once in the morning and once in the evening.
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纳入标准:
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(1)符合高血压病诊断标准,且血压分级为1级或2级的患者;
(2)实验室指标符合早期肾损害标准者;
(3)符合肝阳上亢证的中医证候诊断标准者;
(4)年龄在18岁-79岁的患者;
(5)患者知情并同意参与研究。
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Inclusion criteria
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(1) Patients who meet the diagnostic criteria for hypertension and have a blood pressure classification of grade 1 or 2;
(2) Those whose laboratory indicators meet the criteria for early renal damage;
(3) Those who meet the diagnostic criteria of Chinese medicine symptoms of liver-yang over-excessive syndrome;
(4) Patients aged 18-79 years old;
(5) Patients who were informed and agreed to participate in the study.
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排除标准:
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(1)继发性高血压、高血压急症及高血压危象患者;
(2)原发性肾脏疾病以及其他疾病引起的慢性肾功能不全者;
(3)严重的心脑疾病,如近3个月内有心肌梗塞、心绞痛、心力衰竭、严重的瓣膜疾病患者、脑梗死、脑出血患者;
(4)合并严重靶器官损害、恶性肿瘤、严重感染、免疫功能障碍等重大疾病的患者;
(5)对试验药物有明显禁忌或不耐受;
(6)过敏体质和对多种药物过敏者;
(7)哺乳、妊娠期妇女;
(8)近期服用中药影响辨证分型者;
(9)有精神、认知障碍及依从性差不能配合随访者;
(10)同时参加其他研究者。
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Exclusion criteria:
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(1) Patients with secondary hypertension, hypertensive emergencies and hypertensive crises;
(2) Patients with primary renal disease and chronic renal insufficiency caused by other diseases;
(3) Serious heart and brain diseases, such as myocardial infarction, angina pectoris, heart failure, patients with serious valvular diseases, cerebral infarction, cerebral hemorrhage patients within the last 3 months;
(4) Patients with major diseases combined with severe target organ damage, malignant tumors, severe infections, immune dysfunction and so on;
(5) Obvious contraindication or intolerance to the test drug;
(6) Allergic body and allergic to multiple drugs;
(7) Nursing and pregnant women;
(8) Those who have recently taken traditional Chinese medicine that affects the identification and typing of evidence;
(9) People with mental and cognitive disorders and poor compliance who cannot cooperate with the follow-up;
(10) Participants in other studies at the same time.
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研究实施时间:
Study execute time:
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从From
2024-06-19
至To
2024-12-31
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征募观察对象时间:
Recruiting time:
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从From
2024-06-19
至To
2024-12-31
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