Effect of Green Tea on Treatment of Lupus

Solo los usuarios registrados pueden traducir artículos

Iniciar sesión Registrarse

El enlace se guarda en el portapapeles.

EstadoTerminado

Patrocinadores

Ahvaz Jundishapur University of Medical Sciences

ENSAYO CLÍNICO: NCT02875691

BioSeek: NCT02875691

Palabras clave

Abstracto

This randomized double blind clinical trial performed on 68 patients (32 in intervention and 36 in control group) diagnosed with SLE. The patients in intervention group were given daily dose of 1000mg of aqueous green tea extract (of 6 gram of dried green tea leaf) in form of two capsules ( 500 mg). Also in control group, the patients were given daily dose of 1000mg of cellulose in form of two capsules ( 500 mg) Variables include SLE disease activity, some biomarkers of inflammation and oxidative stress and anthropometric indicators at baseline and end of the study.

The investigators used SLEDAI (systemic lupus erythematous disease activity index ) questionnaire for evaluating the clinical signs of the disease. The questionnaires filled out at baseline and after 3 month.

Descripción

noting

fechas

Verificado por última vez:	04/30/2016
Primero enviado:	05/27/2016
Inscripción estimada enviada:	08/17/2016
Publicado por primera vez:	08/22/2016
Última actualización enviada:	08/17/2016
Última actualización publicada:	08/22/2016
Fecha de inicio real del estudio:	08/31/2015
Fecha estimada de finalización primaria:	02/29/2016
Fecha estimada de finalización del estudio:	02/29/2016

Condición o enfermedad

Autoimmune

Lupus Erythematosus, Systemic

Intervención / tratamiento

Dietary Supplement: green tea extract

Dietary Supplement: Placebo

Fase

Fase 2

Grupos de brazos

Brazo	Intervención / tratamiento
Active Comparator: green tea extract Patients were given daily dose of 1000mg aqueous green tea extract (of 6 grams of dried green tea leaf) in the form of 2 capsules (500 mg) for three months.	Dietary Supplement: green tea extract Patients are given daily dose of 1000mg aqueous green tea extract (of 6 grams of dried green tea leaf) in the form of 2 capsules( 500 mg) for three months.
Placebo Comparator: Placebo Patients in placebo group received daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months	Dietary Supplement: Placebo Patients in placebo group receive daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months

Criterio de elegibilidad

Edades elegibles para estudiar	15 Years A 15 Years
Sexos elegibles para estudiar	Female
Acepta voluntarios saludables	si
Criterios	Inclusion Criteria: The patients older than 15 years,diagnosed with systemic lupus erythematous (SLE) according to ACR(American College of Rheumatology) criteria. Exclusion Criteria: - Patients with other autoimmune diseases (diabetes, ...) - Cardiovascular disease - Patients with infectious or liver disease; - severe infection - Pregnancy - Breastfeeding - Smoking - Alcohol consumption - Use of any dietary supplements - Changing of medication during the study period

Salir

Medidas de resultado primarias

1. systemic lupus erythematous Disease Activity [Three months after starting of intervention]

Clinical signs consist of 24 items, 16 of which are clinical items such as seizure, psychosis, organic brain syndrome, visual disturbance, other neurological problems, hair loss, new rash, muscle weakness, arthritis, blood vessel inflammation, mouth sores, chest pain worse with deep breathing and manifestations of pleurisy and/or pericarditis and fever consistency.Eight of the 24 items are laboratory results such as urinalysis testing, blood complement levels, increase anti-DNA antibody levels, low platelets, and low white blood cell count. these items assessed by SLEDAI questionnaire

Medidas de resultado secundarias

1. measurement of some proinflammatory and anthropometric markers [At baseline and after three months of intervention]

interleukin-6 (IL6), interleukin1β(IL1β , Tumor Necrosis Factor-α (TNF-α),Total Antioxidant Capacity (TAC) of Blood serum will be assessed by enzyme-linked immunosorbent assay (ELISA) at baseline and after three months intervention • Malondialdehyde (MDA) Blood serum MDA will be assessed by Thiobarbituric acid method (TBA)

2. Health-Related Quality of Life [At baseline and after three months of intervention]

Quality of Life will be assessed by12-item Short-Form (SF-12v2) self-report questionnaire ,at baseline and after3 months of intervention

Otras medidas de resultado

1. Dietary intake [at baseline and after 3 month of intervention]

24-Hour dietary recalls questionnaires will be used to assess dietary pattern

2. Weight [at baseline and after 3 month of intervention]

Weight will be measured in kg

3. BMI [at baseline and after 3 month of intervention]

BMI is weight in kilograms divided to height in meters squared

Effect of Green Tea on Treatment of Lupus

Palabras clave

inflamación

celulosa

camellia sinensis

camellia