The Therapeutic Effect of Catgut Embedding in Obesity
- Conditions
- Obese Women
- Interventions
- Device: Catgut embedding groupDevice: sham catgut embedding group
- Registration Number
- NCT02276235
- Lead Sponsor
- Taipei City Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 90
- body mass index (BMI) ≥ 27 kg/m2 waist circumference (WC) ≥ 80 cm and willing to participate in and fill out the questionnaires for this trial.
- Endocrine disease(Thyroid disease, pituitary disease, diabetes mellitus) Autoimmune disease（SLE、SSS、RA） Heart disease(Heart failure, arrhythmia etc.） Abnormal liver function（GOT>80U/L、GPT>80U/L） Abnormal kidney function（serum creatinine>2.5 mg/dL） Stroke disease in past one year Under breast feeding or pregnancy Coagulation disorder Subjects with keloid disorder Accept weight reduction treatment in last two months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description catgut embedding group Catgut embedding group Catgut will be embedding in acupoints as below. Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26) Frequency: one time per week Duration: 6 weeks sham catgut embedding group sham catgut embedding group The stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger without chromic catgut in front of the syringe needle. All the procedure will be performed as in catgut embedding group. Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26) The other procedure were the same as catgut embedding group Frequency: one time per week Duration: 6 weeks
- Primary Outcome Measures
Name Time Method body weight assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks body mass index assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks waist circumference assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks hip circumference assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
- Secondary Outcome Measures
Name Time Method triglyceride (TG) Assess at baseline and after 6 weeks of treatment triglyceride (TG),
sugar Assess at baseline and after 6 weeks of treatment AC sugar,
cholesterol Assess at baseline and after 6 weeks of treatment cholesterol (Chol),
glycohemoglobin Assess at baseline and after 6 weeks of treatment glycohemoglobin (HbA1c),
low-density lipoprotein cholesterol (LDL-C) Assess at baseline and after 6 weeks of treatment low-density lipoprotein cholesterol (LDL-C)
Questionnaire on traditional Chinese medicine syndrome groups Assess at baseline and after 6 weeks of treatment Obesity subjects will be classified into six groups including stomach heat, yin deficiency, qi stagnation, qi deficiency, kidney deficiency and blood stasis With more than two "yes"in items, patient will be classified to that kind of syndrome
kidney function Assess at baseline and after 6 weeks of treatment Cr
inflammatory markers Assess at baseline and after 6 weeks of treatment hsCRP
liver function Assess at baseline and after 6 weeks of treatment ALT
High-density lipoprotein cholesterol(HDL-C) Assess at baseline and after 6 weeks of treatment High-density lipoprotein cholesterol(HDL-C)
Quality of life Assess at baseline and after 6 weeks of treatment short-form 12 items and WHOQOLBREF
Trial Locations
- Locations (1)
Branch of Chinese Medicine, Taipei City Hospital
🇨🇳Taipei, Taiwan