The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension
1 other identifier
interventional
86
0 countries
N/A
Brief Summary
There are few studies in the treatment of hypertension employing acupuncture as a blood pressure regulating technique. The Ministry of Health synthesized the inclusion of integrative and complementary practices within the Unique Health System, such as acupuncture. Our objective is to verify the effect of the acupuncture session on hypertensive patients, measured through ambulatory blood pressure monitoring (ABPM). In this way two groups of patients will be selected in a randomized clinical trial. In the first group, Chinese traditional acupuncture will be applied and in the second group the acupuncture sham will be applied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2018
CompletedFirst Posted
Study publicly available on registry
April 30, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedApril 30, 2018
April 1, 2018
6 months
April 10, 2018
April 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ambulatory Blood Pressure Monitoring
Ambulatory blood pressure monitoring (ABPM) is a feature that enables direct and indirect direct reference to blood pressure in the period 24 or more successive hours with a low level of discomfort throughout the daily activities of the investigated. The possibility of obtaining a representative curve of pressure variations in a given period gives an efficient view of the tension behavior and not simply a static analysis, reflecting only the moment when blood pressure was measured.
24 hours
Study Arms (2)
Acupuncture group
EXPERIMENTALChinese traditional acupuncture
Sham group
PLACEBO COMPARATORSham
Interventions
Eligibility Criteria
You may qualify if:
- patients enrolled in stage I to III of systemic arterial hypertension
- signing the free and informed consent term
You may not qualify if:
- patients who do not agree to participate in the study
- patients with systolic pressure values greater than 180 mmHg or diastolic pressure above 110 mmHg
- patients with important comorbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- silvia goldmeierlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Acupuncture sham will be applied (placebo).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
April 10, 2018
First Posted
April 30, 2018
Study Start
June 1, 2018
Primary Completion
December 1, 2018
Study Completion
June 1, 2019
Last Updated
April 30, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share