Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial

Hong Kong Baptist University1 site in 1 country168 target enrollmentFebruary 1, 2019

ConditionsCentral Obesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Central Obesity
Sponsor: Hong Kong Baptist University
Enrollment: 168
Locations: 1
Primary Endpoint: Changes in waist circumference
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.

Detailed Description

This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.

Registry

clinicaltrials.gov

Start Date

February 1, 2019

End Date

February 28, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hong Kong Baptist University

Responsible Party

Principal Investigator

Zhong Lidan

Research Assistant Professor

Hong Kong Baptist University

Eligibility Criteria

Inclusion Criteria

•Patients who meet all of the following criteria are defined as eligible participants: men and women aged between 18 and 65 years old; BMI ≥ 25 kg/m2; central obesity, defined as WC of ≥ 90 cm in men and ≥ 80 cm in non-pregnant women according to ICD-10 \[24\]; not receiving any other weight control measures or any medical and/or drug history in last 3months.

Exclusion Criteria

•Patients who meet any of the following criteria should be excluded from the study: endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating women; impaired hepatic or renal function; stroke or unable to exercise.

Outcomes

Primary Outcomes

Changes in waist circumference

Time Frame: 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks

Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).

Secondary Outcomes

Changes in hip circumference(0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks)
Adverse events after treatment and follow up(0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks)
Changes in waist-to-hip circumference ratio(0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks)
Changes in Body Mass Index(0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks)
Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG)(0, 8 weeks)
Changes in body fat percentage(0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks)