- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02066090
Acupuncture for Obesity on Serum Metabolic Parameters
Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Seoul, Korea, Republik von, 134-727
- Kyung Hee University Korean Medicine Hospital at Gangdong
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Real acupuncture
manual acupuncture + electroacupuncture, twice a week, for 6 weeks
|
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 |
Schein-Komparator: Sham acupuncture
sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
|
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) |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
change in serum metabolic profile
Zeitfenster: before treatment at week1 (baseline) and after treatment at week6 (endpoint)
|
before treatment at week1 (baseline) and after treatment at week6 (endpoint)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
change in body weight
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: baseline, 1, 2, 3, 4, 5, and 6 weeks
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
|
|
change in hip circumference
Zeitfenster: baseline, 1, 2, 3, 4, 5, and 6 weeks
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
|
|
change in Beck Depression Index (BDI)
Zeitfenster: baseline and 6 weeks
|
baseline and 6 weeks
|
|
change in Social Readjustment Rating Scale (SRRS)
Zeitfenster: baseline and 6 weeks
|
baseline and 6 weeks
|
|
change in Stress Response Inventory (SRI)
Zeitfenster: baseline and 6 weeks
|
baseline and 6 weeks
|
|
change in International Physical Activity Questionnaire (IPAQ)
Zeitfenster: baseline and 6 weeks
|
baseline and 6 weeks
|
|
change in Fatigue Severity Scale (FSS)
Zeitfenster: baseline, 1, 2, 3, 4, 5, and 6 weeks
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
|
|
heart rate variability (HRV)
Zeitfenster: 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
Zeitfenster: up to the end of study
|
|
up to the end of study
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
change in Measure Yourself Medical Outcome Profile (MYMOP)
Zeitfenster: 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)
Zeitfenster: baseline and 6 weeks
|
outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
|
baseline and 6 weeks
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Mi-Yeon Song, Ph.D., Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KHNMCOH 2013-01-020
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Real acupuncture
-
University of MinnesotaNoch keine Rekrutierung
-
University of Southern CaliforniaAbgeschlossenDiabetes MellitusVereinigte Staaten
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; University of Magdeburg; University of WaterlooRekrutierung
-
ji hyun baek, MD, Ph.DRekrutierungDepressionKorea, Republik von
-
University Hospital of FerraraAbgeschlossenMinimal bewusster Zustand | TBIItalien
-
IRCCS Centro San Giovanni di Dio FatebenefratelliRekrutierung
-
Real Prevention, LLCZurückgezogen
-
Mathematica Policy Research, Inc.Office of Population Affairs, Department of Health and Human ServicesAbgeschlossen
-
IRCCS Centro Neurolesi "Bonino-Pulejo"Abgeschlossen
-
Real Imaging Ltd.Unbekannt