The Therapeutic Effect of Catgut Embedding in Obesity
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ClinicalTrials.gov Identifier: NCT02276235 |
Recruitment Status : Unknown
Verified October 2014 by Chung-Hua Hsu, Taipei City Hospital.
Recruitment status was: Enrolling by invitation
First Posted : October 28, 2014
Last Update Posted : October 28, 2014
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Tracking Information | |||
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First Submitted Date ICMJE | October 14, 2014 | ||
First Posted Date ICMJE | October 28, 2014 | ||
Last Update Posted Date | October 28, 2014 | ||
Study Start Date ICMJE | January 2014 | ||
Estimated Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | The Therapeutic Effect of Catgut Embedding in Obesity | ||
Official Title ICMJE | The Therapeutic Effect of Catgut Embedding in Obesity-A Randomized, Double-blind, Placebo-controlled Clinical Trial | ||
Brief Summary | The aim of this double-blind, randomized, placebo-controlled trial is to evaluate the therapeutic effects of acupoint stimulation by catgut embedding on complexion, quality of life, lipid profile, inflammatory markers, and obesity-related hormone peptide of obese women. | ||
Detailed Description | We will recruit 90 females aged from 16 year-old to 65 year-old with body mass index(BMI) 27㎞/㎡ and waist circumference≧80cm. After inform consent, they will be randomly assigned into two groups. In group A, catgut embedding will be applied to six acupuncture points on the abdomen including Qihai (Ren-6), Shuifen (REN-9), bilateral shuidao (ST-28) and Siman (ST-26), which have been proved to be effective on obesity in our previous study, once each week for six times. In group B, sham catgut embedding will be applied on the same acupoints once each week for six weeks. This trial will go on for six weeks with six course of treatment. Our primary outcome measurements is complexion which included body mass index(BMI),waist circumstances, and waist-hip ratio. In our second outcome measurments, we will evaluate the life quality of these patients using 12-Item Short Form Health Survey (SF-12) which developed for the Medical Outcomes Study (MOS) and also using questionnaire of quality of life that was designated by World Health Organization. We will also classify the patients by questionnaire designed for TCM syndrome of obesity. We will check blood test included lipid profile (TG, Chol, HDL-C, LDL-C), inflammatory markers, and hormone peptide related to obesity such as insulin,leptin,ghrelin,adiponectin. Each enrolling patients will be evaluated at the baseline before treatment and after 6 times treatments completed by above parameters to find out the therapeutic effects and mechanism of catgut embedding in acupoints in obese women. |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 4 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Obese Women | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Estimated Enrollment ICMJE |
90 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date ICMJE | December 2014 | ||
Estimated Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 65 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Taiwan | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02276235 | ||
Other Study ID Numbers ICMJE | 101XDAA00024 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Chung-Hua Hsu, Taipei City Hospital | ||
Study Sponsor ICMJE | Taipei City Hospital | ||
Collaborators ICMJE | National Yang Ming University | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Taipei City Hospital | ||
Verification Date | October 2014 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |