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The Therapeutic Effect of Catgut Embedding in Obesity

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

Tracking Information
First Submitted Date  ICMJE October 14, 2014
First Posted Date  ICMJE October 28, 2014
Last Update Posted Date October 28, 2014
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Therapeutic Effect of Catgut Embedding in Obesity
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obese Women
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02276235
Other Study ID Numbers  ICMJE 101XDAA00024
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chung-Hua Hsu, Taipei City Hospital
Study Sponsor  ICMJE Taipei City Hospital
Collaborators  ICMJE National Yang Ming University
Investigators  ICMJE Not Provided
PRS Account Taipei City Hospital
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP