Arterial HypertensionNCT03512106
The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension
A study testing Acupuncture in people with Arterial Hypertension, run by silvia goldmeier.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients enrolled in stage I to III of systemic arterial hypertension
- signing the free and informed consent term
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Arterial Hypertension
- Being tested
- Acupuncture
- Keywords
- Arterial Hypertension, Acupuncture
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Chinese traditional acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Chinese traditional acupuncture Receives: Other: Acupuncture |
| Sham group | Placebo comparator | Sham Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Jun 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Chinese traditional acupuncture will be applied.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- silvia goldmeier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, silvia goldmeier, Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512106
- Sponsor's protocol ID
- Acupuncture
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension
- ClinicalTrials.gov ID
- NCT03512106
- Acronym / sponsor ID
- Acupuncture
- Conditions
- Arterial Hypertension
- Keywords
- Arterial Hypertension, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- silvia goldmeierUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 30 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Chinese traditional acupuncture will be applied.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: AcupunctureChinese traditional acupuncture |
| Sham group | Placebo comparator | Other: AcupunctureSham |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients enrolled in stage I to III of systemic arterial hypertension
- signing the free and informed consent term
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureChinese traditional acupuncture | Other | Acupuncture group, Sham group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Arterial Hypertension, run by silvia goldmeier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Goldmeier, PhD (+5551992431342, sgoldmeier@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory Blood Pressure Monitoring (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.