The Therapeutic Effect of Catgut Embedding in Obesity

NCT02276235 | Unknown Phase 4 DMC

• 1 other identifier: 101XDAA00024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese Women

Keywords

catgut embedding; obese women; obesity-related hormones

Outcome Measures

Primary Outcomes (4)

• body weight

  assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks

• body mass index

  assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks

• waist circumference

  assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks

• hip circumference

  assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks

Secondary Outcomes (11)

• cholesterol

  Assess at baseline and after 6 weeks of treatment

• triglyceride (TG)

  Assess at baseline and after 6 weeks of treatment

• low-density lipoprotein cholesterol (LDL-C)

  Assess at baseline and after 6 weeks of treatment

• High-density lipoprotein cholesterol(HDL-C)

  Assess at baseline and after 6 weeks of treatment

• Quality of life

  Assess at baseline and after 6 weeks of treatment

Study Arms (2)

catgut embedding group

EXPERIMENTAL

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

sham catgut embedding group

SHAM COMPARATOR

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

Interventions

Catgut embedding group DEVICE

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)

Also known as: acupoint catgut embedding

catgut embedding group

sham catgut embedding group DEVICE

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)

Also known as: sham acupoint catgut embedding

sham catgut embedding group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei City Hospital: lead
• National Yang Ming Chiao Tung University: collaborator

Study Sites (1)

Branch of Chinese Medicine, Taipei City Hospital

Taipei, Taiwan, 886, Taiwan

Location

Related 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. No abstract available.

  PMID: 22773366 RESULT

• 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.

  PMID: 25112111 RESULT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief medical officer

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 28, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

TW (1)