ObesityPhase 3NCT00969267
The Effect of Auricular Point Stimulation on Obese Women
A Phase 3 study testing ear-acupuncture A, stimulation B and stimulation C in people with Obesity, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
The aim of the study is to examine whether the ear acupoint stimulation is effective on obese women. Read more about this study
- Who is it for?
- Ages 16 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- ear-acupuncture A, stimulation B and stimulation C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2009to Jul 2010
- 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 16 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 16-65 years women
- BMI>27 kg/mm
- Signed informed consent
Who cannot join
- Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.
- Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.
- Allergy and Immunology disease.
- High aminotransferases ( Alanine, Aspartate > 80 IU/L) or high serum creatinine (> 2.5 mg/dL)
- Pregnant or lactating women.
- Childbirth within 6 months.
Show all 10Show fewer
- Stroke or otherwise unable to exercise
- Management for weight control within 3 months.
- Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.
- Endocrine disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Auricular Point Stimulation on Obese Women: a Randomized Controlled Trial
The aim of the study is to examine whether the ear acupoint stimulation is effective on obese women.
Read the detailed description
% change body weight, BMI, lipid profile, glucose and obese hormone.
- Conditions
- Obesity
- Being tested
- ear-acupuncture A, stimulation B, stimulation C
- Keywords
- ear acupuncture, obese, obese women, women
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ear-acupuncture AOther
Also called ear acupuncture needle
with needle stimulation
stimulation BOther
Also called ear acupuncture bread
with bread stimulation on ear acupuncture point
stimulation COther
Also called placebo needle
without needle stimulation
| Study group | Role | What they receive |
|---|---|---|
| Stimulation A | Experimental | with needle A stimulation Receives: Other: ear-acupuncture A |
| Stimulation B | Active comparator | with stimulation Receives: Other: stimulation B |
| Stimulation C | Sham comparator | without needle Receives: Other: stimulation C |
What is being measured
The primary outcome is the main question the study is designed to answer.
% reducting of body mass index (BMI)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Principal investigator, Chung-Hua Hsu, Taipei City Hospital
- Investigators
- Chung-Hua Hsu, MD, PhD, Principal investigator, Insitute of Traditional Medicine, National Yang Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969267
- Sponsor's protocol ID
- 98001-62-020
- Status last verified
- May 2014
- First submitted
- 31 Aug 2009
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu CH, Wang CJ, Hwang KC, Lee TY, Chou P, Chang HH. The effect of auricular acupuncture in obese women: a randomized controlled trial. J Womens Health (Larchmt). 2009 Jun;18(6):813-8. doi: 10.1089/jwh.2008.1005.
PubMed 19445642Hsu CH, Hwang KC, Chao CL, Lin JG, Kao ST, Chou P. Effects of electroacupuncture in reducing weight and waist circumference in obese women: a randomized crossover trial. Int J Obes (Lond). 2005 Nov;29(11):1379-84. doi: 10.1038/sj.ijo.0802997.
PubMed 15953937Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.
PubMed 18468736
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Auricular Point Stimulation on Obese Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00969267
- Acronym / sponsor ID
- 98001-62-020
- Conditions
- Obesity
- Keywords
- ear acupuncture, obese, obese women, women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Sep 2009 (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 aim of the study is to examine whether the ear acupoint stimulation is effective on obese women.
Detailed description
% change body weight, BMI, lipid profile, glucose and obese hormone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stimulation A | Experimental | Other: ear-acupuncture Awith needle A stimulation |
| Stimulation B | Active comparator | Other: stimulation Bwith stimulation |
| Stimulation C | Sham comparator | Other: stimulation Cwithout needle |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 16-65 years women
- BMI>27 kg/mm
- Signed informed consent
Key exclusion criteria (10 listed)
- Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.
- Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.
- Allergy and Immunology disease.
- High aminotransferases ( Alanine, Aspartate > 80 IU/L) or high serum creatinine (> 2.5 mg/dL)
- Pregnant or lactating women.
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 |
|---|---|---|
| ear-acupuncture AAlso: ear acupuncture needlewith needle stimulation | Other | Stimulation A |
| stimulation BAlso: ear acupuncture breadwith bread stimulation on ear acupuncture point | Other | Stimulation B |
| stimulation CAlso: placebo needlewithout needle stimulation | Other | Stimulation C |
Primary outcome
% reducting of body mass index (BMI)
Time frame: 4 weeks
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 29 May 2014.
- Background: PubMed 19445642Hsu CH, Wang CJ, Hwang KC, Lee TY, Chou P, Chang HH. The effect of auricular acupuncture in obese women: a randomized controlled trial. J Womens Health (Larchmt). 2009 Jun;18(6):813-8. doi: 10.1089/jwh.2008.1005.
- Background: PubMed 15953937Hsu CH, Hwang KC, Chao CL, Lin JG, Kao ST, Chou P. Effects of electroacupuncture in reducing weight and waist circumference in obese women: a randomized crossover trial. Int J Obes (Lond). 2005 Nov;29(11):1379-84. doi: 10.1038/sj.ijo.0802997.
- Background: PubMed 18468736Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.
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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.
Chung-Hua Hsu, MD, PhD principal investigator
Insitute of Traditional Medicine, National Yang Ming University
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 ear-acupuncture A, stimulation B and stimulation C in people with Obesity, run by Taipei City Hospital at 1 site in Taiwan.
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 3 inclusion and 10 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 29 May 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 Taiwan. 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. 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.
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?
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.
What does the primary outcome measure?
% reducting of body mass index (BMI) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00969267, which also lists 3 linked publications.
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 29 May 2014.