- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02066090
Acupuncture for Obesity on Serum Metabolic Parameters
Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Seoul, Corea, república de, 134-727
- Kyung Hee University Korean Medicine Hospital at Gangdong
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
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 |
Comparador falso: 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) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
change in serum metabolic profile
Periodo de tiempo: before treatment at week1 (baseline) and after treatment at week6 (endpoint)
|
before treatment at week1 (baseline) and after treatment at week6 (endpoint)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change in body weight
Periodo de tiempo: baseline, 1, 2, 3, 4, 5, and 6 weeks
|
using bioelectrical impedance analysis (BIA)
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baseline, 1, 2, 3, 4, 5, and 6 weeks
|
change in body fat mass
Periodo de tiempo: baseline, 1, 2, 3, 4, 5, and 6 weeks
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using bioelectrical impedance analysis (BIA)
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baseline, 1, 2, 3, 4, 5, and 6 weeks
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change in muscle mass
Periodo de tiempo: 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
Periodo de tiempo: baseline, 1, 2, 3, 4, 5, and 6 weeks
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baseline, 1, 2, 3, 4, 5, and 6 weeks
|
|
change in hip circumference
Periodo de tiempo: baseline, 1, 2, 3, 4, 5, and 6 weeks
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baseline, 1, 2, 3, 4, 5, and 6 weeks
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|
change in Beck Depression Index (BDI)
Periodo de tiempo: baseline and 6 weeks
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baseline and 6 weeks
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change in Social Readjustment Rating Scale (SRRS)
Periodo de tiempo: baseline and 6 weeks
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baseline and 6 weeks
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change in Stress Response Inventory (SRI)
Periodo de tiempo: baseline and 6 weeks
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baseline and 6 weeks
|
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change in International Physical Activity Questionnaire (IPAQ)
Periodo de tiempo: baseline and 6 weeks
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baseline and 6 weeks
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change in Fatigue Severity Scale (FSS)
Periodo de tiempo: baseline, 1, 2, 3, 4, 5, and 6 weeks
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baseline, 1, 2, 3, 4, 5, and 6 weeks
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|
heart rate variability (HRV)
Periodo de tiempo: 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)
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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)
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number of participants with adverse events
Periodo de tiempo: up to the end of study
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up to the end of study
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change in Measure Yourself Medical Outcome Profile (MYMOP)
Periodo de tiempo: baseline, 1, 2, 3, 4, 5, and 6 weeks
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outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
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change in EuroQol-5 Dimension (EQ-5D)
Periodo de tiempo: baseline and 6 weeks
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outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
|
baseline and 6 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mi-Yeon Song, Ph.D., Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KHNMCOH 2013-01-020
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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