Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000933257
Ethics application status
Approved
Date submitted
28/10/2009
Date registered
30/10/2009
Date last updated
19/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Research on equivalence of high blood pressure diagnosed by conventional medicine and traditional Chinese medicine
Scientific title
Morbidity research of traditional Chinese medicine patterns as related to conventional medicine diseases: An observational study on systemic arterial hypertension
Secondary ID [1] 252921 0
#1
Universal Trial Number (UTN)
U1111-1112-3272
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
systemic arterial hypertension 252070 0
Condition category
Condition code
Cardiovascular 252272 252272 0 0
Hypertension
Alternative and Complementary Medicine 252273 252273 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Subjects will be assessed by an interviewer for evaluation of specific symptoms of systemic arterial hypertension related to traditional Chinese medicine. Each patient will be interviewed once during approximately 30 minutes.
Overall duration of this study is 1 year.
Intervention code [1] 241464 0
Not applicable
Comparator / control treatment
Results will be compared to diagnosis made by conventional medicine practitioners on high blood pressure. The diagnostic criteria of systemic arterial hypertension are systolic and diastolic arterial blood pressure equal to, or higher than, 140 and 90 mmHg, respectively, measured in two or more consecutive visits at the outpatient clinic over a period of at least 7 days. Brachial systolic and diastolic blood pressures will be measured on the right arm with a mercury column sphygmomanometer. Each visit will last approximately 20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 253145 0
Morbidity of traditional Chinese medicine patterns related to systemic arterial hypertension. Demographic and clinical data (age, systolic pressure, diastolic pressure, mean blood pressure, pulse pressure, heart rate, and body mass index) are presented as mean and standard deviation (SD) according to hypertension-related pattern subgroups.
Timepoint [1] 253145 0
Imediatelly after interview.
Primary outcome [2] 253153 0
Frequency of manifestations (signs and symptoms) related to high blood pressure obtained from the questionnaires. Descriptive statistics will be used to asses the reults.
Timepoint [2] 253153 0
Imediatelly after interview.
Secondary outcome [1] 262044 0
Statistical correlation among clinical variables and manifestations.
Timepoint [1] 262044 0
Imediatelly after interview.

Eligibility
Key inclusion criteria
Clinical diagnosis of systemic arterial hypertension.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of comorbidities such as diabetes and kidney failure.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
6/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2299 0
Brazil
State/province [1] 2299 0
Rio de Janeiro

Funding & Sponsors
Funding source category [1] 243934 0
University
Name [1] 243934 0
Augusto Motta University Center
Country [1] 243934 0
Brazil
Funding source category [2] 243935 0
Hospital
Name [2] 243935 0
National Institute of Cardiology
Country [2] 243935 0
Brazil
Primary sponsor type
University
Name
Augusto Motta University Center
Address
Avenida Paris, 72 - Bonsucesso, RJ
CEP 21041-020
Country
Brazil
Secondary sponsor category [1] 251291 0
Hospital
Name [1] 251291 0
National Institute of Cardiology
Address [1] 251291 0
R. das Laranjeiras, 374 - Laranjeiras, RJ
CEP 22240-006
Country [1] 251291 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244048 0
Comite de Etica em Pesquisa
Ethics committee address [1] 244048 0
R. das Laranjeiras, 374 - Laranjeiras, RJ
CEP 22240-006
Ethics committee country [1] 244048 0
Brazil
Date submitted for ethics approval [1] 244048 0
Approval date [1] 244048 0
06/01/2009
Ethics approval number [1] 244048 0
0239/02.06.2009

Summary
Brief summary
Systemic arterial hypertension is the leading risk factor for cardiovascular disease. Its diagnosis is based on repetitive blood pressure evaluations. Traditional Chinese medicine reports that diagnosis is based on manifestations (i.e., signs & symptoms) and no other measure is needed to diagnose a subject.
The aim of this work is to evaluate possible associations between conventional medice and traditional Chinese medicine in identifying subjects high blood pressure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30427 0
Address 30427 0
Country 30427 0
Phone 30427 0
Fax 30427 0
Email 30427 0
Contact person for public queries
Name 13674 0
Arthur de Sa Ferreira
Address 13674 0
Avenida Paris, 72 – Bonsucesso, RJ
CEP 21041-020
Country 13674 0
Brazil
Phone 13674 0
+55 21 2714-0984
Fax 13674 0
Email 13674 0
arthur_sf@ig.com.br
Contact person for scientific queries
Name 4602 0
Arthur de Sa Ferreira
Address 4602 0
Avenida Paris, 72 – Bonsucesso, RJ
CEP 21041-020
Country 4602 0
Brazil
Phone 4602 0
+55 21 2714-0984
Fax 4602 0
Email 4602 0
arthur_sf@ig.com.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.