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The Efficacy and Safety of Huoxuo Qianyang Qutan Dection in the Treatment of Hypertension: a Randomized, Double-blind, Placebo-controlled Trial

注册号：

Registration number：

ITMCTR2000003526

最近更新日期：

Date of Last Refreshed on：

2020-07-31

注册时间：

Date of Registration：

2020-07-31

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

随机、双盲、安慰剂对照评价活血潜阳祛痰方干预高血压的疗效和安全性研究方案

Public title：

The Efficacy and Safety of Huoxuo Qianyang Qutan Dection in the Treatment of Hypertension: a Randomized, Double-blind, Placebo-controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

随机、双盲、安慰剂对照评价活血潜阳祛痰方干预高血压的疗效和安全性研究方案

Scientific title：

The Efficacy and Safety of Huoxuo Qianyang Qutan Dection in the Treatment of Hypertension: a Randomized, Double-blind, Placebo-controlled Trial

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

ChiCTR2000035092 ; ChiMCTR2000003526

申请注册联系人：

谢君

研究负责人：

符德玉

Applicant：

Jun Xie

Study leader：

Deyu Fu

申请注册联系人电话：

Applicant telephone：

+86 15562592866

研究负责人电话：

Study leader's telephone：

+86 18616376015

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

550482956@qq.com

研究负责人电子邮件：

Study leader's E-mail：

fdy65@126.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

上海市虹口区甘河路110号心内科

研究负责人通讯地址：

上海市虹口区甘河路110号心内科

Applicant address：

Department of Cardiology, 110 Ganhe Road, Hongkou District, Shanghai, China

Study leader's address：

Department of Cardiology, 110 Ganhe Road, Hongkou District, Shanghai, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

上海中医药大学附属岳阳中西医结合医院

Applicant's institution：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2020—036

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Ethic Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2020/7/6 0:00:00

伦理委员会联系人：

殷从全

Contact Name of the ethic committee：

Congquan Yin

伦理委员会联系地址：

上海市虹口区甘河路110号8号楼伦理办公室

Contact Address of the ethic committee：

Ethics Office, 110 Ganhe Road, Hongkou District, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市虹口区甘河路110号心内科

Primary sponsor's address：

Department of Cardiology, 110 Ganhe Road, Hongkou District, Shanghai, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

具体地址：

甘河路110号

Institution
hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Address：

110 Ganhe Road

经费或物资来源：

上海市科学技术委员会

Source(s) of funding：

Science and Technology Commission of Shanghai Municipality

研究疾病：

高血压

研究疾病代码：

Target disease：

hypertension

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

1.通过规范的随机、双盲、安慰剂对照研究，评价活血潜阳祛痰方对高血压的临床疗效和安全性。 2.观察活血潜阳祛痰方对其他心血管风险因子的影响，为中医药防治高血压相关心脑血管疾病提供科学依据。 3.初步建立高血压病二级预防与心脑血管疾病一级预防管理的中医药防治新模式；构建中医药防治慢性病的科研队伍。

Objectives of Study：

1. A standard randomized, double-blind, placebo-controlled study was conducted to evaluate the clinical efficacy and safety of huoxuoqianyang expectorant for hypertension. 2. To observe the effects of activating blood circulation qianyang expectorant on other cardiovascular risk factors, so as to provide scientific basis for TCM prevention and treatment of hypertension and cerebrovascular diseases. 3. Establish a new TCM prevention and treatment model for secondary prevention of hypertension and primary prevention and management of cardiovascular and cerebrovascular diseases;To build a scientific research team for TCM prevention and treatment of chronic diseases.

药物成份或治疗方案详述：

1..研究用药 活血潜阳祛痰方（免煎颗粒），由丹参9g、川芎9g、钩藤15g、石决明30g、桑寄生15g等组成，具有活血化瘀、平肝潜阳、祛痰的功效。 安慰剂，内含与活血潜阳祛痰方相同成分的中药，但剂量仅为治疗用药的1/10，加赋形剂和调味剂制成与治疗用药色泽、口味相近的颗粒剂。 服法：以幵水溶解后冲服，每天2次，每次1袋。 2. 干预方案 对照组均采用西药治疗+安慰剂，同时进行生活方式的指导；治疗组在维持西药治疗和生活方式指导基础上，给予活血潜阳祛痰方（免煎颗粒）。具体措施如下： （1）生活方式指导的主要包括（参照《中国高血压防治指南（2018修订版）》）： —减少钠盐摄入，每人每日食盐摄入量逐步降至＜6g，增加钾摄入 —合理膳食，平衡膳食； —控制体重，使BMI＜24；腰围＜90cm；女性＜85cm —不吸烟，彻底戒烟，避免被动吸烟； —不饮酒或限制饮酒（每日酒精摄入量男性不超过25g，女性不超过15g；每周酒精摄入量 男性不超过140g，女性不超过80g。白酒、葡萄酒、啤酒摄入量分别少于50ml、100ml、 300ml）； —增加运动，中等强度；每周4-7次；每次持续30-60分钟； —减轻精神压力，保持心理平衡。 （2）活血潜阳祛痰方（免煎颗粒）由江阴天江药业有限公司提供，每日一剂，水冲服，早晚两次分服，每4周为一个疗程，共3个疗程。

Description for medicine or protocol of treatment in detail：

1 Research medication Huoxue Qianyang Qutan Recipe (Mianjian Granules) is composed of 9g Salvia Miltiorrhizae, 9g Ligusticum chuanxiong, 15g Uncaria, 30g Shijue Ming, 15g Morus sylvestris, etc. It has the effects of promoting blood circulation and removing blood stasis, calming liver and suppressing yang, and expectorant. Placebo contains traditional Chinese medicine with the same ingredients as Huoxue Qianyang Qutan Recipe, but the dosage is only 1/10 of the therapeutic medicine, and excipients and flavoring agents are added to make granules similar in color and taste to the therapeutic medicine. Dosage: Dissolve in water and take 1 sachet twice a day. 2 intervention plan The control group was treated with western medicine + placebo, and lifestyle guidance was given at the same time; the treatment group was given Huoxue Qianyang Qutan Recipe (Mianjian granules) on the basis of maintaining western medicine treatment and lifestyle guidance. The specific measures are as follows: (1) Lifestyle guidance mainly includes (refer to "Guidelines for Prevention and Treatment of Hypertension in China (2018 Revised Edition)"): Reduce sodium intake, gradually reduce daily salt intake per person to < 6g, increase potassium intake -Reasonable diet, balanced diet; Control body weight so that BMI < 24; waist circumference < 90cm; female < 85cm -Do not smoke, quit smoking completely, and avoid passive smoking; -Do not drink or limit alcohol consumption (daily alcohol intake should not exceed 25g for men and 15g for women; weekly alcohol intake It should not exceed 140g for men and 80g for women. The intake of liquor, wine and beer is less than 50ml, 100ml, 300ml respectively); -Increase exercise, moderate intensity; 4-7 times a week; each time lasts 30-60 minutes; -Reduce mental pressure and maintain mental balance. (2) Huoxue Qianyang Qutan Recipe (Mianjian Granules) is provided by Jiangyin Tianjiang Pharmaceutical Co., Ltd., one dose per day, mixed with water, twice in the morning and evening, every 4 weeks is a course of treatment, a total of 3 courses.

纳入标准：

（1）门诊或住院的符合1、2级原发性高血压患者；年龄18岁～75岁，男女不限； （2）符合中医“阳亢-血瘀-痰浊”症候诊断标准； （3）在了解本研究内容的情况下，能清楚回答问题，自愿参加并签署知情同意书。

Inclusion criteria

(1) Outpatient or hospitalized patients with primary hypertension of grade 1 and 2; aged from 18 to 75 years, regardless of gender; (2) Meet the diagnostic criteria of "Yang hyperactivity-blood stasis-phlegm turbidity" in traditional Chinese medicine; (3) Under the circumstance of understanding the content of this research, can answer the questions clearly, participate voluntarily and sign the informed consent form.

排除标准：

（1）妊娠，或近期准备妊娠，或哺乳期妇女； （2）严重的心、肝、肾功能损害及其他系统严重的甚至威胁生命的疾病； （3）研究对象本人因酗酒、智障等原因不能配合； （4）其他研究者认为不适宜入选的其他情况； （5）正在参加其他临床研究者； （6）对多种药物过敏者。

Exclusion criteria：

(1) Women who are pregnant, or are about to become pregnant in the near future, or are breast-feeding; (2) Severe damage to heart, liver, kidney function and other serious or even life-threatening diseases; (3) Research subjects cannot cooperate due to alcoholism, intellectual disability, etc.; (4) Other situations deemed inappropriate by other researchers; (5) Those who are participating in other clinical research; (6) Those who are allergic to multiple drugs.

研究实施时间：

Study execute time：

从From 2019-09-01

至To      2022-06-30

征募观察对象时间：

Recruiting time：

从From 2020-08-01

至To      2022-03-31

干预措施：

Interventions：

组别：

试验组

样本量：

119

Group：

treatment group

Sample size：

干预措施：

西药治疗方案+活血潜阳祛痰方

干预措施代码：

Intervention：

Western medicine treatment plan +Huoxue Qianyang Qutan decotion

Intervention code：

组别：

对照组

样本量：

119

Group：

control group

Sample size：

干预措施：

西药治疗方案+安慰剂

干预措施代码：

Intervention：

Western medicine treatment plan + the placebo

Intervention code：

样本总量 Total sample size ： 238

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

单位级别：

三级

Institution/hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

中医证候疗效评定

指标类型：

次要指标

Outcome：

Efficacy evaluation of TCM syndromes

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

Measure time point of outcome：

Before and after treatment

Measure method：

指标中文名：

家庭收缩压、舒张压变化

指标类型：

次要指标

Outcome：

Changes in family systolic and diastolic blood pressure

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

Measure time point of outcome：

Before and after treatment

Measure method：

指标中文名：

诊室收缩压

指标类型：

主要指标

Outcome：

Systolic pressure in the clinic

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

Measure time point of outcome：

Before and after treatment

Measure method：

指标中文名：

诊室舒张压

指标类型：

次要指标

Outcome：

diastolic pressure in the clinic

Type：

Secondary indicator

测量时间点：

治疗4周、8周和12周后

测量方法：

Measure time point of outcome：

After 4, 8 and 12 weeks of treatment

Measure method：

指标中文名：

24小时动态血压平均收缩压、平均舒张压、白天段和夜间段收缩压及舒张压变化

指标类型：

次要指标

Outcome：

24 h mean systolic blood pressure, mean diastolic blood pressure, daytime and nighttime systolic blood pressure and diastolic blood pressure changes

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

Measure time point of outcome：

Before and after treatment

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 75 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本试验为严格的随机对照临床研究，按照随机分配中随机数字表的方法按治疗组和对照组1:1的方案进行随机分组，治疗周期为12周。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This trial is a strict randomized controlled clinical study, which is randomized into the treatment group and the control group according to the method of random number table in random allocation. The treatment cycle is 12 weeks.

盲法：

本研究采用双盲单模拟设计。药物包装与分配：按照双盲临床试验规范化操作步骤，对试验药与对照药进行重新包装和分配。

Blinding：

Double blind single simulation design was adopted in this study.Drug packaging and distribution: Repackaging and distribution of test drugs and control drugs according to standardized procedures of double-blind clinical trials.

是否共享原始数据：

IPD sharing：

是

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

Not stated

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not stated

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Not stated

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Not stated

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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