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Lowering blood pressure effect of indigenous Lebanese plants: Ethnopharmacology and a clinical trial
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注册号：

Registration number：

 ChiCTR1900021653 

最近更新日期：

Date of Last Refreshed on：

 2019-03-03 10:18:41 

注册时间：

Date of Registration：

 2019-03-03 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Lowering blood pressure effect of indigenous Lebanese plants: Ethnopharmacology and a clinical trial

Public title：

Lowering blood pressure effect of indigenous Lebanese plants: Ethnopharmacology and a clinical trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Lowering blood pressure effect of indigenous Lebanese plants: Ethnopharmacology and a clinical trial

Scientific title：

Lowering blood pressure effect of indigenous Lebanese plants: Ethnopharmacology and a clinical trial

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：

申请注册联系人：

MIRNA FAWAZ 

研究负责人：

ALI SAMAHA 

Applicant：

MIRNA FAWAZ 

Study leader：

ALI SAMAHA 

申请注册联系人电话：

Applicant telephone：

 +96 13785199

研究负责人电话：

Study leader's
telephone：

+96 13681559

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：

 mirna.fawaz@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

 mirna.fawaz@hotmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 Beirut Arab University

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：

TAREEK AL JADIDA, BEIRUT, LEBANON

研究负责人通讯地址：

TAREEK AL JADIDA, BEIRUT, LEBANON

Applicant address：

TAREEK AL JADIDA, BEIRUT, LEBANON

Study leader's address：

TAREEK AL JADIDA, BEIRUT, LEBANON

申请注册联系人邮政编码：

Applicant postcode：

 1504

研究负责人邮政编码：

Study leader's postcode：

 1504

申请人所在单位：

黎巴嫩贝鲁特阿拉伯大学

Applicant's institution：

Beirut Arab University

研究负责人所在单位：

黎巴嫩贝鲁特阿拉伯大学

Affiliation of the Leader：

Beirut Arab University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 ECO-R-90

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Institutional Review Board

Name of the ethic committee：

Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

Dr. Hassan Ayoub

Contact Name of the ethic committee：

Dr. Hassan Ayoub

伦理委员会联系地址：

Rayak University Hospital

Contact Address of the ethic committee：

Rayak University Hospital

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：

黎巴嫩贝鲁特阿拉伯大学

Primary sponsor：

Beirut Arab University

研究实施负责（组长）单位地址：

TAREEK AL JADIDA, BEIRUT, LEBANON

Primary sponsor's address：

TAREEK AL JADIDA, BEIRUT, LEBANON

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

None

Source(s) of funding：

none

研究疾病：

高血压  

Target disease：

Hypertension

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

This study aims to document ethnopharmacological traditional knowledge of wild medicinal plants used in the treatment of hypertension and clinically test the blood lowering effect of some selected species.  

Objectives of Study：

This study aims to document ethnopharmacological traditional knowledge of wild medicinal plants used in the treatment of hypertension and clinically test the blood lowering effect of some selected species.

药物成份或治疗方案详述：

The three medicinal plants; M. longifolia, V. odorata and U. dioica selected based on the ethnopharmacological survey will be examined for their antihypertension properties on subjects with mild hypertension. The trial will take the form of 16 week, single-blind, placebo controlled approach and will be conducted under the approval of the IRB of RH hospital that is accredited by the Ministry of Public Health, Lebanon. For the purpose of obtaining this approval, a focus group consisting of a group of cardiologists and nephrologists of the RH hospital will be informed with study background, rational and approach. Written consents assuring participating subjects that all information would be confidential and used only for research purposes will be obtained. Selection criteria will include subjects of 40-65 years of age with mild HTN (SBP: 135 and 139 mmHg and/or DBP: 85 and 89 mmHg) who are not willing to take any pharmaceutical medications but are undergoing life style modifications (salt restriction) with, however, no detectable BP lowering response. Exclusion criteria will include lactating or pregnant females, history of allergy, kidney dysfunction, diabetes or any cardiovascular dysfunction. During the selection process, subjects will attend 2 screening visits at an interval of 2 weeks, each of which included medical and life-style histories, physical examinations, laboratory tests and measurements of BP. Selected subjects will be randomly divided into four groups (three active and one placebo) each consisting of 7-8 subjects based on their taste preference. Selected subjects will be instructed to take a dose of 300 ml/day every morning before breakfast for 16 weeks. SBPs, DBPs and MAPs all participating subjects will be monitored at weeks 4, 8, 12 and 16 by the same physician. Systolic and diastolic BPs will be measured from the left arm using a mercury sphyngomanometer. Measurements will be performed repeated for three times at intervals of 10-min in a sitting position. Safety will be assessed by general physical examination and subjects reports about experiencing any incidence of treatment related adverse events throughout the treatment and post treatment follow up periods.  

Description for medicine or protocol of treatment in detail：

The three medicinal plants; M. longifolia, V. odorata and U. dioica selected based on the ethnopharmacological survey will be examined for their antihypertension properties on subjects with mild hypertension. The trial will take the form of 16 week, single-blind, placebo controlled approach and will be conducted under the approval of the IRB of RH hospital that is accredited by the Ministry of Public Health, Lebanon. For the purpose of obtaining this approval, a focus group consisting of a group of cardiologists and nephrologists of the RH hospital will be informed with study background, rational and approach. Written consents assuring participating subjects that all information would be confidential and used only for research purposes will be obtained. Selection criteria will include subjects of 40-65 years of age with mild HTN (SBP: 135 and 139 mmHg and/or DBP: 85 and 89 mmHg) who are not willing to take any pharmaceutical medications but are undergoing life style modifications (salt restriction) with, however, no detectable BP lowering response. Exclusion criteria will include lactating or pregnant females, history of allergy, kidney dysfunction, diabetes or any cardiovascular dysfunction. During the selection process, subjects will attend 2 screening visits at an interval of 2 weeks, each of which included medical and life-style histories, physical examinations, laboratory tests and measurements of BP. Selected subjects will be randomly divided into four groups (three active and one placebo) each consisting of 7-8 subjects based on their taste preference. Selected subjects will be instructed to take a dose of 300 ml/day every morning before breakfast for 16 weeks. SBPs, DBPs and MAPs all participating subjects will be monitored at weeks 4, 8, 12 and 16 by the same physician. Systolic and diastolic BPs will be measured from the left arm using a mercury sphyngomanometer. Measurements will be performed repeated for three times at intervals of 10-min in a sitting position. Safety will be assessed by general physical examination and subjects reports about experiencing any incidence of treatment related adverse events throughout the treatment and post treatment follow up periods.  

纳入标准：

Inclusion criteria

排除标准：

Exclusion criteria will include lactating or pregnant females, history of allergy, kidney dysfunction, diabetes or any cardiovascular dysfunction.

Exclusion criteria：

Exclusion criteria will include lactating or pregnant females, history of allergy, kidney dysfunction, diabetes or any cardiovascular dysfunction.

研究实施时间：

Study execute time：

从 From 2016-10-01 00:00:00至 To 2018-09-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2016-10-01 00:00:00 至 To 2018-07-21 00:00:00

干预措施：

Interventions：

组别：

Placebo Group

样本量：

 7

Group：

Placebo Group

Sample size：

干预措施：

Placebo

干预措施代码：

Intervention：

Placebo

Intervention code：

组别：

VO Group

样本量：

 7

Group：

VO Group

Sample size：

干预措施：

V. odorata

干预措施代码：

Intervention：

V. odorata

Intervention code：

组别：

UD Group

样本量：

 8

Group：

UD Group

Sample size：

干预措施：

U. dioica

干预措施代码：

Intervention：

U. dioica

Intervention code：

组别：

ML Group

样本量：

 7

Group：

ML Group

Sample size：

干预措施：

M. longifolia

干预措施代码：

Intervention：

M. longifolia

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 黎巴嫩

省(直辖市)：

 贝卡 

市(区县)：

 Chtaura 

Country：

Lebanon

Province：

Bekaa

City：

Chtaura

单位(医院)：

 Rayak University Hospital 

单位级别：

  

Institution
hospital：

Rayak University Hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Blood Pressure

指标类型：

主要指标

Outcome：

Blood Pressure

Type：

Primary indicator

测量时间点：

测量方法：

Sphygmomanometer

Measure time point of outcome：

Measure method：

Sphygmomanometer

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

No

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：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 40 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Selected subjects were randomly divided into four groups (three active and one placebo) each consisting of 7-8 subjects based on their taste preference.

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

Selected subjects were randomly divided into four groups (three active and one placebo) each consisting of 7-8 subjects based on their taste preference.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Not stated

Blinding：

Not stated

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-03-03 10:18:41
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