- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03512106
The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension
April 18, 2018 updated by: silvia goldmeier
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.
Study Overview
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
Enrollment (Anticipated)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Silvia Goldmeier, PhD
- Phone Number: +5551992431342
- Email: sgoldmeier@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupuncture group
Chinese traditional acupuncture
|
Chinese traditional acupuncture
|
Placebo Comparator: Sham group
Sham
|
Chinese traditional acupuncture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2018
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
June 1, 2019
Study Registration Dates
First Submitted
April 10, 2018
First Submitted That Met QC Criteria
April 18, 2018
First Posted (Actual)
April 30, 2018
Study Record Updates
Last Update Posted (Actual)
April 30, 2018
Last Update Submitted That Met QC Criteria
April 18, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- acupuncture
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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