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Acupuncture for Obesity on Serum Metabolic Parameters

K

Kyung Hee University

Status

Completed

Conditions

Obesity

Treatments

Device: Real acupuncture
Device: Sham acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT02066090
KHNMCOH 2013-01-020

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 patients

Sex

Female

Ages

19 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • volunteers through announcements and advertisements
  • premenopausal adult women (19 years of age or more)
  • clinical diagnosis of obesity (Body mass index: 25 kg/m2 or more)

Exclusion criteria

  • previously or currently having endocrine disease such as hypothyroidism or Cushing's syndrome, heart disease, lung disease, diabetes, malignant tumor, cholelithiasis, severe kidney impairment, severe liver impairment, anorexia nervosa or hyperorexia
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

Real acupuncture
Experimental group
Description:
manual acupuncture + electroacupuncture, twice a week, for 6 weeks
Treatment:
Device: Real acupuncture
Sham acupuncture
Sham Comparator group
Description:
sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
Treatment:
Device: Sham acupuncture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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