The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension
Primary Purpose
Arterial Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by

About this trial
This is an interventional treatment trial for Arterial Hypertension focused on measuring Arterial Hypertension, Acupuncture
Eligibility Criteria
Inclusion Criteria:
- patients enrolled in stage I to III of systemic arterial hypertension
- signing the free and informed consent term
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acupuncture group
Sham group
Arm Description
Chinese traditional acupuncture
Sham
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03512106
Brief Title
The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension
Official Title
The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
silvia goldmeier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Acupuncture as therapy is the subject of conflicting opinions on its effectiveness in scientific means, because in spite of its long existence as a therapeutic tool, raises doubts on the standards of Western science model. In addition, 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. The World Health Organization (WHO) recognizes its effectiveness, having its own concept in the energy imbalance that alter the organic, mental and emotional part addressing a current issue proposing to groundbreaking research. The 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension
Keywords
Arterial Hypertension, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Chinese traditional acupuncture will be applied.
Masking
Outcomes Assessor
Masking Description
Acupuncture sham will be applied (placebo).
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
Chinese traditional acupuncture
Arm Title
Sham group
Arm Type
Placebo Comparator
Arm Description
Sham
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Chinese traditional acupuncture
Primary Outcome Measure Information:
Title
Ambulatory Blood Pressure Monitoring
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients enrolled in stage I to III of systemic arterial hypertension
signing the free and informed consent term
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Goldmeier, PhD
Phone
+5551992431342
Email
sgoldmeier@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension
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