HypertensionPhase 1NCT00459680
Acupuncture and Laser Acupoint Treatment on Hypertension
A Phase 1 study testing Laser acupoint treatment and Acupuncture in people with Hypertension, run by Logan College of Chiropractic at 1 site in United States.
Trial summary
To determine the effect of acupuncture and laser acupuncture point treatment on hypertensive subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Laser acupoint treatment and Acupuncture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jun 2009
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over 18 and under 70 years of age with hypertension (blood pressure over 140/90 mmhg).
Who cannot join
- Individuals with heart, kidney, thyroid disorders, diabetes, chronic disease or illness, neurological diseases, skin or bleeding disorders, and currently taking drugs or medications will not be recruited in the study. A health history questionnaire will be used to screen the subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Logan College of Chiropractic
Chesterfield, Missouri, 63017
John Zhang, MD, PhD, 636-230-1920, john.zhang@logan.edu
About this study
To determine the effect of acupuncture and laser acupuncture point treatment on hypertensive subjects.
Read the detailed description
The specific aims of the study are to test the effectiveness of acupuncture and laser acupoint on hypertension. The hypothesis is: the stimulation of a pattern of acupoints with acupuncture and laser will result in significant reductions in blood pressure. The points that are going to be used for the study are: Zusanli (St36), Tianshu (St25), Quchi (LI11).
- Conditions
- Hypertension
- Being tested
- Laser acupoint treatment, Acupuncture
- Keywords
- hypertension, acupuncture, laser
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupoint treatmentDevice
Also called Laser
Laser
AcupunctureProcedure or surgery
Needle acupuncture on ST36 and LI11.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Not described Receives: Procedure: Acupuncture |
| Laser Acupoint | Experimental | Not described Receives: Device: Laser acupoint treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: Pretreatment then at 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startFeb 2008
- Primary completionJan 2009 (estimated)
- Study completionJun 2009 (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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Investigators
- John Zhang, MD. PhD, Principal investigator, Logan College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459680
- Sponsor's protocol ID
- LCC-05-06
- Status last verified
- Oct 2008
- First submitted
- 10 Apr 2007
- Last updated
- 21 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Laser Acupoint Treatment on Hypertension
- ClinicalTrials.gov ID
- NCT00459680
- Acronym / sponsor ID
- LCC-05-06
- Conditions
- Hypertension
- Keywords
- hypertension, acupuncture, laser
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 12 Apr 2007 (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.
To determine the effect of acupuncture and laser acupuncture point treatment on hypertensive subjects.
Detailed description
The specific aims of the study are to test the effectiveness of acupuncture and laser acupoint on hypertension. The hypothesis is: the stimulation of a pattern of acupoints with acupuncture and laser will result in significant reductions in blood pressure. The points that are going to be used for the study are: Zusanli (St36), Tianshu (St25), Quchi (LI11).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: Acupuncture |
| Laser Acupoint | Experimental | Device: Laser acupoint treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female over 18 and under 70 years of age with hypertension (blood pressure over 140/90 mmhg).
Key exclusion criteria (1 listed)
- Individuals with heart, kidney, thyroid disorders, diabetes, chronic disease or illness, neurological diseases, skin or bleeding disorders, and currently taking drugs or medications will not be recruited in the study. A health history questionnaire will be used to screen the subjects.
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 |
|---|---|---|
| Laser acupoint treatmentAlso: LaserLaser | Device | Laser Acupoint |
| AcupunctureNeedle acupuncture on ST36 and LI11. | Procedure or surgery | Acupuncture |
Primary outcome
Blood pressure
Time frame: Pretreatment then at 2 and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2010.
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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.
John Zhang, MD. PhD principal investigator
Logan College of Chiropractic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laser acupoint treatment and Acupuncture in people with Hypertension, run by Logan College of Chiropractic 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 1 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 21 Jan 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Pretreatment then at 2 and 4 weeks). 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 21 Jan 2010.