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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

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.

Condition or disease Intervention/treatment Phase
Obese Women Device: Catgut embedding group Device: sham catgut embedding group Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Therapeutic Effect of Catgut Embedding in Obesity-A Randomized, Double-blind, Placebo-controlled Clinical Trial
Study Start Date : January 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Arm Intervention/treatment
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
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

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

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




Primary Outcome Measures :
  1. body weight [ Time Frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks ]
  2. body mass index [ Time Frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks ]
  3. waist circumference [ Time Frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks ]
  4. hip circumference [ Time Frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks ]

Secondary Outcome Measures :
  1. cholesterol [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
    cholesterol (Chol),

  2. triglyceride (TG) [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
    triglyceride (TG),

  3. low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
    low-density lipoprotein cholesterol (LDL-C)

  4. High-density lipoprotein cholesterol(HDL-C) [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
    High-density lipoprotein cholesterol(HDL-C)

  5. Quality of life [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
    short-form 12 items and WHOQOLBREF

  6. 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

  7. sugar [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
    AC sugar,

  8. glycohemoglobin [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
    glycohemoglobin (HbA1c),

  9. liver function [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
    ALT

  10. kidney function [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
    Cr

  11. inflammatory markers [ Time Frame: Assess at baseline and after 6 weeks of treatment ]
    hsCRP



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276235


Locations
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Taiwan
Branch of Chinese Medicine, Taipei City Hospital
Taipei, Taiwan, 886
Sponsors and Collaborators
Taipei City Hospital
National Yang Ming University

Publications of Results:
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Responsible Party: Chung-Hua Hsu, chief medical officer, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT02276235    
Other Study ID Numbers: 101XDAA00024
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Chung-Hua Hsu, Taipei City Hospital:
catgut embedding
obese women
obesity-related hormones
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms