Effect of Green Tea on Treatment of Lupus

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Ahvaz Jundishapur University of Medical Sciences

КЛИНИЧЕСКИЕ ИСПЫТАНИЯ: NCT02875691

BioSeek: NCT02875691

Ключевые слова

абстрактный

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.

Описание

noting

Даты

Последняя проверка:	04/30/2016
Первый отправленный:	05/27/2016
Предполагаемая регистрация отправлена:	08/17/2016
Первое сообщение:	08/22/2016
Последнее обновление отправлено:	08/17/2016
Последнее обновление опубликовано:	08/22/2016
Фактическая дата начала исследования:	08/31/2015
Предполагаемая дата завершения начальной школы:	02/29/2016
Предполагаемая дата завершения исследования:	02/29/2016

Состояние или болезнь

Autoimmune

Lupus Erythematosus, Systemic

Вмешательство / лечение

Dietary Supplement: green tea extract

Dietary Supplement: Placebo

Фаза

Фаза 2

Группы рук

Рука	Вмешательство / лечение
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

Критерии приемлемости

Возраст, имеющий право на обучение	15 Years Чтобы 15 Years
Полы, имеющие право на обучение	Female
Принимает здоровых добровольцев	да
Критерии	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

Результат

Основные показатели результатов

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

Меры вторичного результата

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

Другие показатели результатов

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