The Therapeutic Effect of Catgut Embedding in Obesity-A Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
body weight
时间窗: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
body mass index
时间窗: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
waist circumference
时间窗: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
hip circumference
时间窗: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
次要结局
- triglyceride (TG)(Assess at baseline and after 6 weeks of treatment)
- sugar(Assess at baseline and after 6 weeks of treatment)
- cholesterol(Assess at baseline and after 6 weeks of treatment)
- glycohemoglobin(Assess at baseline and after 6 weeks of treatment)
- low-density lipoprotein cholesterol (LDL-C)(Assess at baseline and after 6 weeks of treatment)
- Questionnaire on traditional Chinese medicine syndrome groups(Assess at baseline and after 6 weeks of treatment)
- kidney function(Assess at baseline and after 6 weeks of treatment)
- inflammatory markers(Assess at baseline and after 6 weeks of treatment)
- liver function(Assess at baseline and after 6 weeks of treatment)
- High-density lipoprotein cholesterol(HDL-C)(Assess at baseline and after 6 weeks of treatment)
- Quality of life(Assess at baseline and after 6 weeks of treatment)
研究者
Chung-Hua Hsu
chief medical officer
Taipei City Hospital