The Therapeutic Effect of Catgut Embedding in Obesity

• ClinicalTrials.gov Identifier: NCT02276235
• Recruitment Status: Unknown
• First Posted: October 28, 2014
• Last Update Posted: October 28, 2014
• Sponsor: Taipei City Hospital
• Collaborator: National Yang Ming University
• Information provided by (Responsible Party): Chung-Hua Hsu, Taipei City Hospital

Tracking Information

• First Submitted Date: October 14, 2014
• First Posted Date: October 28, 2014
• Last Update Posted Date: October 28, 2014
• Study Start Date: January 2014
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 23, 2014)

• body weight [ Time Frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks ]
• body mass index [ Time Frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks ]
• waist circumference [ Time Frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks ]
• hip circumference [ Time Frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks ]

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 23, 2014)

• cholesterol [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
  cholesterol (Chol),
• triglyceride (TG) [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
  triglyceride (TG),
• low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
  low-density lipoprotein cholesterol (LDL-C)
• High-density lipoprotein cholesterol(HDL-C) [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
  High-density lipoprotein cholesterol(HDL-C)
• Quality of life [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
  short-form 12 items and WHOQOLBREF
• Questionnaire on traditional Chinese medicine syndrome groups [ Time Frame: 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
• sugar [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
  AC sugar,
• glycohemoglobin [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
  glycohemoglobin (HbA1c),
• liver function [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
  ALT
• kidney function [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
  Cr
• inflammatory markers [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
  hsCRP

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Obese Women

Intervention

• Device: Catgut embedding group

  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)

  Other Name: acupoint catgut embedding
• Device: 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. 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)

  Other Name: sham acupoint catgut embedding

Study Arms

• Experimental: 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
  Intervention: Device: Catgut embedding group
• Sham Comparator: 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

  Intervention: Device: sham catgut embedding group

Publications *

• 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. Review.
• 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. Review. Chinese.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 23, 2014): 90
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2014
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT02276235
• Other Study ID Numbers: 101XDAA00024
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Chung-Hua Hsu, Taipei City Hospital
• Study Sponsor: Taipei City Hospital
• Collaborators: National Yang Ming University
• Investigators: Not Provided
• PRS Account: Taipei City Hospital
• Verification Date: October 2014