An interventional study of Real acupuncture and Sham acupuncture in Obesity, sponsored by Kyung Hee University Hospital at Gangdong. Completed at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by Kyung Hee University Hospital at Gangdong · Not applicable, Interventional, and Treatment
This research is planned to build a basis about the effect of acupuncture on serum metabolic parameters in pre-menopausal obese women with economic evaluation.
It is consisted with two sub research.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 120 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Kyung Hee University Hospital at Gangdong is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
manual acupuncture + electroacupuncture, twice a week, for 6 weeks
Device: Real acupuncture
sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
Device: Sham 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 (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)
change in serum metabolic profile
Time frame: before treatment at week1 (baseline) and after treatment at week6 (endpoint)
change in body weight
using bioelectrical impedance analysis (BIA)
Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
change in body fat mass
using bioelectrical impedance analysis (BIA)
Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
change in muscle mass
using bioelectrical impedance analysis (BIA)
Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
change in waist circumference
Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
change in hip circumference
Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
change in Beck Depression Index (BDI)
Time frame: baseline and 6 weeks
change in Social Readjustment Rating Scale (SRRS)
Time frame: baseline and 6 weeks
change in Stress Response Inventory (SRI)
Time frame: baseline and 6 weeks
change in International Physical Activity Questionnaire (IPAQ)
Time frame: baseline and 6 weeks
change in Fatigue Severity Scale (FSS)
Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
heart rate variability (HRV)
Time frame: just before treatment at visit1(baseline), 10 minutes after treatment at visit1, just before treatment at visit12 (6 weeks), 10 minutes after treatment at visit12(end point)
number of participants with adverse events
* assessment of severity: mild, moderate, severe * assessment of relation: definitely related, probably related, possibly related, probably not related, definitely not related, unknown
Time frame: up to the end of study
change in Measure Yourself Medical Outcome Profile (MYMOP)
outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
change in EuroQol-5 Dimension (EQ-5D)
outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
Time frame: baseline and 6 weeks
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Kyung Hee University Hospital at Gangdong