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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02276235
Other study ID # 101XDAA00024
Secondary ID
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:

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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


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
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