Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-01-02 @ 10:14 PM
Study NCT ID:
NCT02276235
Status:
UNKNOWN
Last Update Posted:
2014-10-28
First Post:
2014-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Therapeutic Effect of Catgut Embedding in Obesity
Sponsor:
Taipei City Hospital
Organization:
Study Overview
Official Title:
The Therapeutic Effect of Catgut Embedding in Obesity-A Randomized, Double-blind, Placebo-controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2014-10
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: