Ontology highlight
ABSTRACT:
Objective: This clinical trial aims to evaluate the effectiveness and safety of CIA used for treatment of simple obesity.
Methods: This is a multicentre, randomized, parallel, sham-controlled clinical trial. A total of 216 patients with simple obesity will be recruited. They will be randomly assigned in a 1:1 ratio to either the CIA group or the sham control group. All treatments will be given once every 2 weeks. The primary outcome measure is the rate of waistline reduction. Secondary outcome measures are the rates of reduction of body measurements, including weight, body mass index (BMI), hipline, waist-hip-ratio (WHR) and body fat percentage (BFP), the changes in scores on scales, including the Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite), Short Form 36 (SF-36), the Hospital Anxiety and Depression Scale (HAD) and the Self-Esteem Scale (SES), Outcomes will be evaluated at baseline and at weeks 4, 8, 12, 16, 28, and 40, respectively. All adverse events that occur during this study will be recorded. If any participant withdraws from the trial, an intention-to-treat analysis (ITT) will be performed.
Conclusion: This is a randomized, sham-controlled trial of CIA treatment for simple obesity. The results of this trial will provide more evidence on whether CIA is efficacious and safe for treating obesity.
Trial registration: ClinicalTrials.gov Identifier: NCT02936973. Registered on October 18, 2016.
SUBMITTER: Chen X
PROVIDER: S-EPMC7710253 | biostudies-literature | 2020 Nov
REPOSITORIES: biostudies-literature
Chen Xia X Huang Wei W Wei Dan D Ding De-Guang DG Jiao Yang Y Pan Hong-Ling HL Jin Yi-Ting YT Zheng Yi-Wei YW Zhang Yan-Ji YJ Zhang Ying-Rong YR Liu Yi-Ran YR Zhou Zhong-Yu ZY
Medicine 20201101 48
<h4>Background</h4>Catgut implantation at acupoints (CIA) is a subtype of acupuncture that has been widely used to treat simple obesity, but evidence for its effectiveness remains scarce. The aim of this study is to evaluate the efficacy and safety of treating simple obesity with CIA.<h4>Objective</h4>This clinical trial aims to evaluate the effectiveness and safety of CIA used for treatment of simple obesity.<h4>Methods</h4>This is a multicentre, randomized, parallel, sham-controlled clinical t ...[more]