NCT04957134

Efficacy of Electro-acupuncture for Abdominal Obesity: Study for a Randomized Controlled Trial

The Efficacy and Safety of Electro-acupuncture for Abdominal Obesity: Original Study for a Multicenter, Randomized, Sham-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Hubei Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Electro-acupuncture provides stimulation to acupoints, and has been widely used to treat abdominal obesity in China despite of lack of high-level evidence for treatment efficacy. The study will investigate whether the electroacupuncture can alleviate clinical symptoms and the mechanism of action in patients with abdominal obesity.

Detailed description

The study will be a randomized controlled trial from May 2021 to December 2022, including 68 participants with abdominal obesity. The participants will be randomly divided into 2 groups in a 1:1 allocation ratio.The intervention group will receive electroacupuncture; the control group will receive sham acupuncture. Each treatment will last 12 weeks, including 8 weeks of intervention period and 24 weeks of follow-up. The primary outcome is the waist circumference (WC), the secondary outcomes include weight, body mass index (BMI), hipline, waist-hip-ratio (WHR), Insulin resistance index (IRI), blood fat, metabolomics will be used analysis the mechanism. The adverse events will be recorded during the intervention and follow-up period.

Conditions

• Obesity, Abdominal

Interventions

Type	Name	Description
DEVICE	Electro-acupuncture	The acupoints of electro-acupuncture will be selected as Zusanli ,Sanyinjiao ,Zhongwan , Tianshu , Shuifen , Daheng ,Daimai , Shuidao ,Huaroumen and Fujie . We will deliver electrical stimulation with dense-disperse waves at 50 Hz and 10 V through the electrical acupuncture stimulation instrument to the abdominal points. The bodily needles will be retained for 30 minutes . Electro-acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.
DEVICE	Sham electro-acupuncture	The acupoints of sham electro-acupuncture will be selected as nonacupoints . The internal output power cord of the electrical acupuncture stimulation instrument will be interrupted. The bodily needles will be retained for 30 minutes . Sham acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.

Timeline

• Start date: 2021-07-22
• Primary completion: 2023-03-15
• Completion: 2023-03-15
• First posted: 2021-07-12
• Last updated: 2023-06-12

Locations

1 site across 1 country: China