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A multicenter cross-sectional study on the distribution characteristics of traditional Chinese medicine symptoms in normal high blood pressure population

Registration number：

ITMCTR2024000770

Date of Last Refreshed on：

2024-12-03

Date of Registration：

2024-12-03

Registration Status：

Prospective registration

Public title：

A multicenter cross-sectional study on the distribution characteristics of traditional Chinese medicine symptoms in normal high blood pressure population

English Acronym：

Scientific title：

An evaluation study on the clinical efficacy of Tanyutongzhi antihypertensive decoction in the intervention of high normal blood pressure population

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Jing Tianyue

Study leader：

Wang Liying

Applicant telephone：

+86 18515515675

Study leader's telephone：

+86 158 1090 9001

Applicant Fax：

Study leader's fax：

Applicant E-mail：

moonseaxxx@163.com

Study leader's E-mail：

coldmoon_ly@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

China Academy of Chinese Medical Sciences 16 Dongzhimennei Nanxiaojie Dongcheng Beijing

Study leader's address：

China Academy of Chinese Medical Sciences 16 Dongzhimennei Nanxiaojie Dongcheng Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Science

Approved by ethic committee：

Approved No. of ethic committee：

P24015-PJ15

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Review Committee Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2024/10/8 0:00:00

Contact Name of the ethic committee：

Yu Xueyun

Contact Address of the ethic committee：

16 Dongzhimennei Nanxiaojie Dongcheng District Beijing China

Contact phone of the ethic committee：

+86 10 6408 7789

Contact email of the ethic committee：

chengguochu2021@163.com

Primary sponsor：

Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences

Primary sponsor's address：

16 Dongzhimennei Nanxiaojie Dongcheng District Beijing China

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences

Address：

16 Dongzhimennei Nanxiaojie Dongcheng District Beijing China

Source(s) of funding：

Capitals Funds for Health Improvement and Research

Target disease：

High Normal Blood Pressure

Target disease code：

Study type：

Observational study

Study design：

Cross-sectional

Study phase：

Others

Objectives of Study：

To reveal the distribution characteristics of traditional Chinese medicine symptoms in the normal high blood pressure population through cross-sectional study and provide data support for subsequent scientific research.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Subjects voluntarily participate and sign the informed consent form; 2. Subjects can complete various questionnaire surveys; 3. Age range: 18 years old ≤ age < 65 years old; 4. Individuals with normal high blood pressure levels ranging from 120 to 139 mmHg (systolic) and 80 to 89 mmHg (diastolic).

Exclusion criteria：

1. Individuals already diagnosed with primary or secondary hypertension; 2. Patients with severe primary diseases of the heart brain liver kidneys and hematopoietic system or mental illness; 3. Pregnant and lactating women.

Study execute time：

From 2024-12-15

To      2026-12-31

Recruiting time：

From 2024-12-15

To      2025-05-31

Interventions：

250

Group：

Observation group

Sample size：

Intervention：

N/A

Intervention code：

Total sample size ： 250

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Wangjing Hospital of China Academy of Chinese Medical Sciences

Level of the institution：

Tertiary A

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Hospital of Traditional Chinese Medicine of Capital Medical University

Level of the institution：

Tertiary A

Country：

China

Province：

Beijing

City：

Institution/hospital：

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Level of the institution：

Tertiary A

Country：

China

Province：

Beijing

City：

Institution/hospital：

Dongfang Hospital of Beijing University of Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Pulse condition

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM symptoms

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood pressure

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Basic information

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Heart rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Diagnosis of TCM syndromes

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Tongue manifestation

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Medical history

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

None

Blinding：

IPD sharing：

No

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

None

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

Questionnaire

Data Managemen Committee：

No

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

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