HypertensionNCT00010478
Acupuncture and Hypertension
A study testing Acupuncture in people with Hypertension, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
Although traditional Chinese medicine advocates the use of acupuncture not only to induce analgesia but also to treat essential hypertension, acupuncture's postulated antihypertensive efficacy in humans has not been subjected to rigorous Western scientific testing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with normal blood pressures or blood pressures over 120/80 up to 165/105
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture and Hypertension-Efficacy and Mechanisms
Although traditional Chinese medicine advocates the use of acupuncture not only to induce analgesia but also to treat essential hypertension, acupuncture's postulated antihypertensive efficacy in humans has not been subjected to rigorous Western scientific testing. Before advocating acupuncture as an effective complementary/alternative medicine strategy for essential hypertension, it is necessary to demonstrate that the beneficial effects of acupuncture are scientifically robust, long-lasting, and explicable in terms of modern scientific mechanisms. In spontaneously hypertensive rats, acupuncture-like electrical stimulation of thinly myelinated (Group III) somatic afferents activates central endorphin (naloxone-sensitive) pathways that elicit long-lasting decreases in sympathetic nerve activity (SNA) and blood pressure. The ability to record SNA with microelectrodes in conscious humans provides a new opportunity to test this novel mechanistic hypothesis in patients undergoing electroacupuncture, a modification of the ancient technique that provides a quantifiable and reproducible stimulus to human skeletal muscle afferents. Using a randomized, double-blind placebo-controlled design, we will test the following major hypotheses: Electroacupuncture produces a long-lasting reduction in SNA, thereby providing a safe and effective complementary treatment of human hypertension. Given the enormous interest in acupuncture by our lay public, but the paucity of Western scientific data about its efficacy in cardiovascular disorders, our studies in normotensive and hypertensive humans should provide a conceptual framework for deciding whether to accept or reject the large body of Chinese (and Russian) literature advocating acupuncture as a safe and effective treatment of essential hypertension and other cardiovascular disorders (such as heart failure, and myocardial ischemia).
- Conditions
- Hypertension
- Being tested
- Acupuncture
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010478
- Sponsor's protocol ID
- R01AT000129-02
- Status last verified
- Jul 2006
- First submitted
- 2 Feb 2001
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Hypertension-Efficacy and Mechanisms
- ClinicalTrials.gov ID
- NCT00010478
- Acronym / sponsor ID
- R01AT000129-02
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- First posted
- 5 Feb 2001 (estimated)
- 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.
Although traditional Chinese medicine advocates the use of acupuncture not only to induce analgesia but also to treat essential hypertension, acupuncture's postulated antihypertensive efficacy in humans has not been subjected to rigorous Western scientific testing. Before advocating acupuncture as an effective complementary/alternative medicine strategy for essential hypertension, it is necessary to demonstrate that the beneficial effects of acupuncture are scientifically robust, long-lasting, and explicable in terms of modern scientific mechanisms. In spontaneously hypertensive rats, acupuncture-like electrical stimulation of thinly myelinated (Group III) somatic afferents activates central endorphin (naloxone-sensitive) pathways that elicit long-lasting decreases in sympathetic nerve activity (SNA) and blood pressure. The ability to record SNA with microelectrodes in conscious humans provides a new opportunity to test this novel mechanistic hypothesis in patients undergoing electroacupuncture, a modification of the ancient technique that provides a quantifiable and reproducible stimulus to human skeletal muscle afferents. Using a randomized, double-blind placebo-controlled design, we will test the following major hypotheses: Electroacupuncture produces a long-lasting reduction in SNA, thereby providing a safe and effective complementary treatment of human hypertension. Given the enormous interest in acupuncture by our lay public, but the paucity of Western scientific data about its efficacy in cardiovascular disorders, our studies in normotensive and hypertensive humans should provide a conceptual framework for deciding whether to accept or reject the large body of Chinese (and Russian) literature advocating acupuncture as a safe and effective treatment of essential hypertension and other cardiovascular disorders (such as heart failure, and myocardial ischemia).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with normal blood pressures or blood pressures over 120/80 up to 165/105
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
Related trials for Hypertension
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruitingPhase 2
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Hypertension, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 18 Aug 2006.