Obese Women Clinical Trial
Official title:
The Therapeutic Effect of Catgut Embedding in Obesity-A Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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