The Therapeutic Effect of Catgut Embedding in Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Therapeutic Effect of Catgut Embedding in Obesity-A Randomized, Double-blind, Placebo-controlled Clinical Trial

Conditions
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Obese Women

Intervention / Treatment
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* Device: Catgut embedding group
* Device: sham catgut embedding group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: catgut embedding group<br>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 | Device: Catgut embedding group<br>* An extensive form of acupuncture that involves weekly infixing self-absorptive chromic catgut sutures into acupoints with a specialised needle under antiseptic precautions. The catgut then stimulate those points over a long period. The stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger with chromic catgut in front of the syringe needle. 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)<br>* Other names: acupoint catgut embedding;|
| Sham Comparator: sham catgut embedding group<br>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 | Device: sham catgut embedding group<br>* 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. 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)<br>* Other names: sham acupoint catgut embedding;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cholesterol | cholesterol (Chol), | Assess at baseline and after 6 weeks of treatment | 
| triglyceride (TG) | triglyceride (TG), | Assess at baseline and after 6 weeks of treatment | 
| low-density lipoprotein cholesterol (LDL-C) | low-density lipoprotein cholesterol (LDL-C) | Assess at baseline and after 6 weeks of treatment | 
| High-density lipoprotein cholesterol(HDL-C) | High-density lipoprotein cholesterol(HDL-C) | Assess at baseline and after 6 weeks of treatment | 
| Quality of life | short-form 12 items and WHOQOLBREF | Assess at baseline and after 6 weeks of treatment | 
| Questionnaire on traditional Chinese medicine syndrome groups | 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 yesin items, patient will be classified to that kind of syndrome | Assess at baseline and after 6 weeks of treatment | 
| sugar | AC sugar, | Assess at baseline and after 6 weeks of treatment | 
| glycohemoglobin | glycohemoglobin (HbA1c), | Assess at baseline and after 6 weeks of treatment | 
| liver function | ALT | Assess at baseline and after 6 weeks of treatment | 
| kidney function | Cr | Assess at baseline and after 6 weeks of treatment | 
| inflammatory markers | hsCRP | Assess at baseline and after 6 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catgut embedding, obesity-related hormones, obese women