Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2014-03-31
2016-02-29
Brief Summary
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Detailed Description
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First, clinical research to assess the effect of acupuncture for obesity on serum metabolic parameters will be processed with randomized, patient-assessor blinding, and sham-acupuncture controlled study design. 120 subjects would be collected and divided into two groups(experimental and placebo, 60 subjects each). Experimental group will undergo with real acupuncture treatment(manual acupuncture + electroacupuncture) twice a week, for 6 weeks. The effect on serum metabolic parameters will be assessed at 0 and 6 weeks.
Second is qualitative research to make a basis through the evaluation of economic efficacy and patients' satisfaction with acupuncture treatment for obesity.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Real acupuncture
manual acupuncture + electroacupuncture, twice a week, for 6 weeks
Real acupuncture
manual acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + electroacupuncture (middle CV6, CV12), twice a week, for 6 weeks
common approaches for the treatment of obesity used by doctors of Korean medicine in Korea today
Sham acupuncture
sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
Sham acupuncture
sham acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + placebo acupuncture without electrical stimulation (middle CV6, CV12), twice a week, for 6 weeks
sham acupuncture (0.25mm diameter x 40mm length, stainless steel, Acuprime, UK) as control for manual acupuncture (0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea)
placebo acupuncture without electrical stimulation as control for electroacupuncture (0.25mm diameter x 90mm length, stainless steel, Dongbangacupuncture Inc., Korea)
Interventions
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Real acupuncture
manual acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + electroacupuncture (middle CV6, CV12), twice a week, for 6 weeks
common approaches for the treatment of obesity used by doctors of Korean medicine in Korea today
Sham acupuncture
sham acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + placebo acupuncture without electrical stimulation (middle CV6, CV12), twice a week, for 6 weeks
sham acupuncture (0.25mm diameter x 40mm length, stainless steel, Acuprime, UK) as control for manual acupuncture (0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea)
placebo acupuncture without electrical stimulation as control for electroacupuncture (0.25mm diameter x 90mm length, stainless steel, Dongbangacupuncture Inc., Korea)
Eligibility Criteria
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Inclusion Criteria
* premenopausal adult women (19 years of age or more)
* clinical diagnosis of obesity (Body mass index: 25 kg/m2 or more)
Exclusion Criteria
* experience of taking medicines which might affect body weight and the concentration of serum metabolic parameters such as anorectic, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, or medicines affecting absorption, metabolism, and excretion in the past 3 months
* experience of taking beta-blocker or diuretic for the treatment of hypertension in the past 3 months
* surgical treatment for the treatment of obesity
* currently or might be pregnant or breast-feeding
* experience of taking other experimental medicines in the past month
* weight loss of 10% or more of previous body weight in the past 6 months
* who stopped smoking in the past 3 months or who have irregular smoking habit
* pacemaker
* currently receiving any treatment for obesity
* other inadequate subjects assessed by the study investigators
19 Years
55 Years
FEMALE
No
Sponsors
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Kyung Hee University Hospital at Gangdong
OTHER
Responsible Party
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Mi-Yeon Song
Professor, K.M.D., Ph.D.
Principal Investigators
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Mi-Yeon Song, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital
Locations
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Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, , South Korea
Countries
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References
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Kim KW, Shin WC, Choi MS, Cho JH, Park HJ, Yoo HH, Song MY. Effects of acupuncture on anthropometric and serum metabolic parameters in premenopausal overweight and obese women: a randomized, patient- and assessor-blind, sham-controlled clinical trial. Acupunct Med. 2021 Feb;39(1):30-40. doi: 10.1177/0964528420912259. Epub 2020 Apr 17.
Kim KW, Yoo HH, Cho JH, Yang YC, Kim JI, Kim SY, Park JY, Park HJ, Song MY. Effects of acupuncture on serum metabolic parameters in premenopausal obese women: study protocol for a randomized controlled trial. Trials. 2015 Aug 4;16:327. doi: 10.1186/s13063-015-0867-y.
Other Identifiers
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KHNMCOH 2013-01-020
Identifier Type: -
Identifier Source: org_study_id