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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03512106
Other study ID # Acupuncture
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date June 1, 2019

Study information

Verified date April 2018
Source Instituto de Cardiologia do Rio Grande do Sul
Contact Silvia Goldmeier, PhD
Phone +5551992431342
Email sgoldmeier@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 86
Est. completion date June 1, 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acupuncture
Chinese traditional acupuncture

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
silvia goldmeier

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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