Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Acupuncture for Obesity on Serum Metabolic Parameters

14. november 2017 opdateret af: Mi-Yeon Song, Kyung Hee University Hospital at Gangdong

Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 134-727
        • Kyung Hee University Korean Medicine Hospital at Gangdong

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Real acupuncture
manual acupuncture + electroacupuncture, twice a week, for 6 weeks
Enhed: 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-komparator: Sham acupuncture
sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
Enhed: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
change in serum metabolic profile
Tidsramme: before treatment at week1 (baseline) and after treatment at week6 (endpoint)
before treatment at week1 (baseline) and after treatment at week6 (endpoint)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in body weight
Tidsramme: baseline, 1, 2, 3, 4, 5, and 6 weeks
using bioelectrical impedance analysis (BIA)
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in body fat mass
Tidsramme: baseline, 1, 2, 3, 4, 5, and 6 weeks
using bioelectrical impedance analysis (BIA)
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in muscle mass
Tidsramme: baseline, 1, 2, 3, 4, 5, and 6 weeks
using bioelectrical impedance analysis (BIA)
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in waist circumference
Tidsramme: baseline, 1, 2, 3, 4, 5, and 6 weeks
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in hip circumference
Tidsramme: baseline, 1, 2, 3, 4, 5, and 6 weeks
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in Beck Depression Index (BDI)
Tidsramme: baseline and 6 weeks
baseline and 6 weeks
change in Social Readjustment Rating Scale (SRRS)
Tidsramme: baseline and 6 weeks
baseline and 6 weeks
change in Stress Response Inventory (SRI)
Tidsramme: baseline and 6 weeks
baseline and 6 weeks
change in International Physical Activity Questionnaire (IPAQ)
Tidsramme: baseline and 6 weeks
baseline and 6 weeks
change in Fatigue Severity Scale (FSS)
Tidsramme: baseline, 1, 2, 3, 4, 5, and 6 weeks
baseline, 1, 2, 3, 4, 5, and 6 weeks
heart rate variability (HRV)
Tidsramme: 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)
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
Tidsramme: up to the end of study
  • assessment of severity: mild, moderate, severe
  • assessment of relation: definitely related, probably related, possibly related, probably not related, definitely not related, unknown
up to the end of study

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in Measure Yourself Medical Outcome Profile (MYMOP)
Tidsramme: baseline, 1, 2, 3, 4, 5, and 6 weeks
outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in EuroQol-5 Dimension (EQ-5D)
Tidsramme: baseline and 6 weeks
outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
baseline and 6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kyung Hee University Hospital at Gangdong

Efterforskere

  • Ledende efterforsker: Mi-Yeon Song, Ph.D., Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2014

Primær færdiggørelse (Faktiske)

1. februar 2016

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

14. februar 2014

Først indsendt, der opfyldte QC-kriterier

14. februar 2014

Først opslået (Skøn)

19. februar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KHNMCOH 2013-01-020

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Real acupuncture

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Poland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner