ObesityPhase 3NCT00414505
A Randomized Controlled Double Blinding Study of Intradermal Acupuncture Treatment on Obesity
A Phase 3 study testing Intradermal Acupuncture Treatment in people with Obesity, run by Wonkwang University at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether intradermal acupuncture is effective and safe in the treatment of obesity. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Intradermal Acupuncture Treatment
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2006to Dec 2014
- Phase
- Phase 3
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI>25, regular menstruation, volunteer
Who cannot join
- symptomatic obesity, acupuncture treatment within 3 months, >120kg, pregnancy or breast-feeding, hemophilia, dementia, mental illness, arrhythmia, liver cirrhosis, renal failure, pace maker, diabete mellitus, tuberculosis, steroid taker,
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Wonkwang University Hospital
Gwangju, 503-310
About this study
Official title: Korea Institute of Oriental Medicine
The purpose of this study is to determine whether intradermal acupuncture is effective and safe in the treatment of obesity.
Read the detailed description
Recently the Studies of auricular acupuncture or Common Acupuncture on obesity have been conducted. Saam acupuncture, the Korean unique acupuncture, is famous with its high efficacy but not established by the scientific way yet. Thus, we tried a double-blind study on the effect of sa-am acupuncture on obesity using intradermal acupuncture.
- Conditions
- Obesity
- Being tested
- Intradermal Acupuncture Treatment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal Acupuncture TreatmentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Bio-body impedance methods
Secondary outcomes (1)
Cholesterol, Triglycerides, HDL LDL cholesterol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startAug 2006
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wonkwang University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Investigators
- Sung-chul Kim, Ph.D., Study director, Dept. of Acupuncture & Moxibustion, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414505
- Sponsor's protocol ID
- K06070
- Status last verified
- May 2014
- First submitted
- 20 Dec 2006
- Last updated
- 2 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korea Institute of Oriental Medicine
- ClinicalTrials.gov ID
- NCT00414505
- Acronym / sponsor ID
- K06070
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Wonkwang UniversityUniversity, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Study start
- Aug 2006
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 Dec 2006 (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.
The purpose of this study is to determine whether intradermal acupuncture is effective and safe in the treatment of obesity.
Detailed description
Recently the Studies of auricular acupuncture or Common Acupuncture on obesity have been conducted. Saam acupuncture, the Korean unique acupuncture, is famous with its high efficacy but not established by the scientific way yet. Thus, we tried a double-blind study on the effect of sa-am acupuncture on obesity using intradermal acupuncture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI>25, regular menstruation, volunteer
Key exclusion criteria (1 listed)
- symptomatic obesity, acupuncture treatment within 3 months, >120kg, pregnancy or breast-feeding, hemophilia, dementia, mental illness, arrhythmia, liver cirrhosis, renal failure, pace maker, diabete mellitus, tuberculosis, steroid taker,
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 |
|---|---|---|
| Intradermal Acupuncture Treatment | Device | – |
Primary outcome
Bio-body impedance methods
1 secondary outcome
Cholesterol, Triglycerides, HDL LDL cholesterol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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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.
Sung-chul Kim, Ph.D. study director
Dept. of Acupuncture & Moxibustion, Wonkwang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intradermal Acupuncture Treatment in people with Obesity, run by Wonkwang University at 1 site in South Korea.
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 2 Jun 2014. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Sung-chul Kim (82-62-670-6442, kscndl@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bio-body impedance methods. 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 2 Jun 2014.