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Acupuncture for Body Weight Control

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ClinicalTrials.gov Identifier: NCT02516878
Recruitment Status : Completed
First Posted : August 6, 2015
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
ZhaoXiang Bian, Hong Kong Baptist University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: Acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Acupuncture for Body Weight Control: A Pilot Randomized Controlled Trial
Study Start Date : August 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.


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.

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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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 ]
  3. 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 ]
  4. 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

  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516878


Sponsors and Collaborators
Hong Kong Baptist University
Investigators
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Study Director: Zhaoxiang Bian, MD., Ph.D Hong Kong Baptist University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ZhaoXiang Bian, Professor, Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT02516878     History of Changes
Other Study ID Numbers: AcupBWC001
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017

Keywords provided by ZhaoXiang Bian, Hong Kong Baptist University:
acupuncture
Chinese Medicine
obesity

Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms