Acupuncture for Body Weight Control

Overview

In this study, a 18-week, single-blinded, randomized controlled clinical trial will be conducted to evaluate the effectiveness, efficacy and safety of acupuncture on weight control in Hong Kong.

Full Title of Study: “Acupuncture for Body Weight Control: A Pilot Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 2016

Detailed Description

This is a pilot single-blind, randomized, sham-controlled trial. 72 participants will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 sessions per week and the follow-up period will be 8 weeks.

Interventions

  • Procedure: Acupuncture
    • Eight body acupuncture points will be chosen as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli(ST-36), Fenlong(ST-40), Sanyinjiao(SP-6). The needles will be retained for 30 minutes. Participants of the treatment group will additionally receive unilateral auricular acupressure at four auricular points as Hunger, Shen men, Spleen and Stomach with Semen Vaccariae embedded within adhesive tape in each treatment session. Acupressure will be applied by the subjects with repeat pressing of the tape with fingertips for 3 minutes per point, 3 times per day. The embedded tape will be retained in-situ until the next visit and then the alternate side of ear will be treated.

Arms, Groups and Cohorts

  • Experimental: Acupuncture group
    • Eight body acupuncture points will be chosen as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli(ST-36), Fenlong(ST-40), Sanyinjiao(SP-6). The needles will be retained for 30 minutes. Participants of the treatment group will additionally receive unilateral auricular acupressure at four auricular points as Hunger, Shen men, Spleen and Stomach with Semen Vaccariae embedded within adhesive tape in each treatment session. Acupressure will be applied by the subjects with repeat pressing of the tape with fingertips for 3 minutes per point, 3 times per day. The embedded tape will be retained in-situ until the next visit and then the alternate side of ear will be treated.
  • Sham Comparator: Control group
    • For subjects assigned to control group, Streitberger’s non-invasive acupuncture needles (Gauge 8 x 1.2″ / 0.30 x 30 mm) will be applied to serve as sham control at the same acupoints with the same stimulation modality, except that the needles are only adhered to the skin instead of insertion. The Semen Vaccariae embedded tape used in treatment group will be applied on 4 non-acupoints at the helix unilaterally, retained until the next visit and then the alternate ear will be used.

Clinical Trial Outcome Measures

Primary Measures

  • Change in body weight during treatment and follow up
    • Time Frame: The change in body weight will be assessed every two weeks during 8-week treatment and 8-week follow up
    • measured by Omron KARADA Scan Body Composition & Scale

Secondary Measures

  • Change in Body Mass Index (BMI) during treatment and follow up
    • Time Frame: The change in BMI will be assessed every two weeks during 8-week treatment and 8-week follow up
    • The change in Body Mass Index (BMI) will be measured by Omron KARADA Scan Body Composition & Scale
  • Change in waist circumference during treatment and follow up
    • Time Frame: The change in waist circumference will be assessed every two weeks during 8-week treatment and 8-week follow up
  • Change in hip circumference
    • Time Frame: The change in hip circumference will be assessed every two weeks during 8-week treatment and 8-week follow up
  • Change in body fat percentage during treatment and follow up
    • Time Frame: The change in body fat percentage will be assessed every two weeks during 8-week treatment and 8-week follow up
    • The change in body fat percentage will be measured by Omron KARADA Scan Body Composition & Scale
  • Number of patients with adverse events after treatment
    • Time Frame: Number of patients with adverse events after treatment will be recorded and compared among the two groups during 8-week treatment and 8-week follow up

Participating in This Clinical Trial

Inclusion Criteria

  • aged between 18 and 65 years old; – body mass index (BMI)≥25 kg/m2; – having not received any other weight control measures or any medical and/or drug history within the last 3 months. Exclusion Criteria:

  • endocrine diseases; – heart diseases; – patients with pacemaker; – allergy and immunology diseases; – having bleeding tendency; – pregnant or lactating women; – having impaired hepatic or renal function; – stroke or otherwise unable to exercise.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hong Kong Baptist University
  • Provider of Information About this Clinical Study
    • Principal Investigator: ZhaoXiang Bian, Professor – Hong Kong Baptist University
  • Overall Official(s)
    • Zhaoxiang Bian, MD., Ph.D, Study Director, Hong Kong Baptist University

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