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The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT03512106
Recruitment Status : Not yet recruiting
First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
silvia goldmeier, Instituto de Cardiologia do Rio Grande do Sul

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.

Condition or disease Intervention/treatment Phase
Arterial Hypertension Other: Acupuncture Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Chinese traditional acupuncture will be applied.
Masking: Single (Outcomes Assessor)
Masking Description: Acupuncture sham will be applied (placebo).
Primary Purpose: Treatment
Official Title: The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture group
Chinese traditional acupuncture
Other: Acupuncture
Chinese traditional acupuncture

Placebo Comparator: Sham group
Sham
Other: Acupuncture
Chinese traditional acupuncture




Primary Outcome Measures :
  1. Ambulatory Blood Pressure Monitoring [ Time Frame: 24 hours ]
    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.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512106


Contacts
Contact: Silvia Goldmeier, PhD +5551992431342 sgoldmeier@gmail.com

Sponsors and Collaborators
silvia goldmeier

Responsible Party: silvia goldmeier, PhD, Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03512106     History of Changes
Other Study ID Numbers: Acupuncture
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by silvia goldmeier, Instituto de Cardiologia do Rio Grande do Sul:
Arterial Hypertension
Acupuncture

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases