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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
silvia goldmeier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Hypertension focused on measuring Arterial Hypertension, Acupuncture

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 10, 2018
    Last Updated
    April 18, 2018
    Sponsor
    silvia goldmeier
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    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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