Clinical trial NCT02276235: The Therapeutic Effect of Catgut Embedding in Obesity
Official title: The Therapeutic Effect of Catgut Embedding in Obesity-A Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obese Women
Keywords: catgut embedding
obese women
obesity-related hormones
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2014-10-28
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: body weight
timeFrame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
measure: body mass index
timeFrame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
measure: waist circumference
timeFrame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
measure: hip circumference
timeFrame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
Secondary outcomes:
measure: cholesterol
timeFrame: Assess at baseline and after 6 weeks of treatment
measure: triglyceride (TG)
timeFrame: Assess at baseline and after 6 weeks of treatment
measure: low-density lipoprotein cholesterol (LDL-C)
timeFrame: Assess at baseline and after 6 weeks of treatment
measure: High-density lipoprotein cholesterol(HDL-C)
timeFrame: Assess at baseline and after 6 weeks of treatment
measure: Quality of life
timeFrame: Assess at baseline and after 6 weeks of treatment
measure: Questionnaire on traditional Chinese medicine syndrome groups
timeFrame: Assess at baseline and after 6 weeks of treatment
measure: sugar
timeFrame: Assess at baseline and after 6 weeks of treatment
measure: glycohemoglobin
timeFrame: Assess at baseline and after 6 weeks of treatment
measure: liver function
timeFrame: Assess at baseline and after 6 weeks of treatment
measure: kidney function
timeFrame: Assess at baseline and after 6 weeks of treatment
measure: inflammatory markers
timeFrame: Assess at baseline and after 6 weeks of treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Branch of Chinese Medicine, Taipei City Hospital
Study officials:
References:
citation: Huang CY, Choong MY, Li TS. Treatment of obesity by catgut embedding: an evidence-based systematic analysis. Acupunct Med. 2012 Sep;30(3):233-4. doi: 10.1136/acupmed-2012-010176. Epub 2012 Jul 7. No abstract available.
citation: Liao JQ, Song X, Chen Y, Liang LC, Wang SX. [Clinical randomized controlled trials of acupoint catgut-embedding for simple obesity: a meta-analysis]. Zhongguo Zhen Jiu. 2014 Jun;34(6):621-6. Chinese.