The Therapeutic Effect of Catgut Embedding in Obesity

Obese Women Clinical Trial

Official title:

The Therapeutic Effect of Catgut Embedding in Obesity-A Randomized, Double-blind, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02276235
• Other study ID #: 101XDAA00024
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 14, 2014
• Last updated: October 23, 2014
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: October 2014
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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)
• 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)

Locations

Country	Name	City	State
Taiwan	Branch of Chinese Medicine, Taipei City Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei City Hospital	National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. Review. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight		assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks	No
Primary	body mass index		assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks	No
Primary	waist circumference		assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks	No
Primary	hip circumference		assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks	No
Secondary	cholesterol	cholesterol (Chol),	Assess at baseline and after 6 weeks of treatment	No
Secondary	triglyceride (TG)	triglyceride (TG),	Assess at baseline and after 6 weeks of treatment	No
Secondary	low-density lipoprotein cholesterol (LDL-C)	low-density lipoprotein cholesterol (LDL-C)	Assess at baseline and after 6 weeks of treatment	No
Secondary	High-density lipoprotein cholesterol(HDL-C)	High-density lipoprotein cholesterol(HDL-C)	Assess at baseline and after 6 weeks of treatment	No
Secondary	Quality of life	short-form 12 items and WHOQOLBREF	Assess at baseline and after 6 weeks of treatment	No
Secondary	Questionnaire on traditional Chinese medicine syndrome groups	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	Assess at baseline and after 6 weeks of treatment	No
Secondary	sugar	AC sugar,	Assess at baseline and after 6 weeks of treatment	No
Secondary	glycohemoglobin	glycohemoglobin (HbA1c),	Assess at baseline and after 6 weeks of treatment	No
Secondary	liver function	ALT	Assess at baseline and after 6 weeks of treatment	No
Secondary	kidney function	Cr	Assess at baseline and after 6 weeks of treatment	No
Secondary	inflammatory markers	hsCRP	Assess at baseline and after 6 weeks of treatment	No