|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00969267 |
|
Date of registration:
|
31/08/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Effect of Auricular Point Stimulation on Obese Women
|
|
Scientific title:
|
The Effect of Auricular Point Stimulation on Obese Women: a Randomized Controlled Trial |
|
Date of first enrolment:
|
August 2009 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00969267 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Taiwan
| | | | | | | |
|
Contacts
|
|
Name:
|
Chung-Hua Hsu, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Insitute of Traditional Medicine, National Yang Ming University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age 16-65 years women
- BMI>27 kg/mm
- Signed informed consent
Exclusion Criteria:
- 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.
- 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
Age minimum:
16 Years
Age maximum:
65 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Obesity
|
|
Intervention(s)
|
|
Other: stimulation B
|
|
Other: ear-acupuncture A
|
|
Other: stimulation C
|
|
Primary Outcome(s)
|
|
% reducting of body mass index (BMI)
[Time Frame: 4 weeks]
|
|
Secondary ID(s)
|
|
98001-62-020
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|