Effect of Green Tea on Treatment of Lupus

केवल पंजीकृत उपयोगकर्ता ही लेखों का अनुवाद कर सकते हैं

साइन अप करने के लिए लॉग इन करें

लिंक क्लिपबोर्ड पर सहेजा गया है

स्थितिपूरा कर लिया है

प्रायोजक

Ahvaz Jundishapur University of Medical Sciences

नैदानिक परीक्षण: NCT02875691

BioSeek: NCT02875691

कीवर्ड

सार

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.

विवरण

noting

खजूर

अंतिम सत्यापित:	04/30/2016
पहले प्रस्तुत किया गया:	05/27/2016
अनुमानित नामांकन प्रस्तुत किया गया:	08/17/2016
पहले पोस्ट किया गया:	08/22/2016
अंतिम अद्यतन प्रस्तुत किया:	08/17/2016
अंतिम अद्यतन पोस्ट:	08/22/2016
वास्तविक अध्ययन प्रारंभ दिनांक:	08/31/2015
अनुमानित प्राथमिक समापन तिथि:	02/29/2016
अनुमानित अध्ययन पूर्णता तिथि:	02/29/2016

स्थिति या रोग

Autoimmune

Lupus Erythematosus, Systemic

हस्तक्षेप / उपचार

Dietary Supplement: green tea extract

Dietary Supplement: Placebo

चरण

चरण 2

शाखा समूह

बांह	हस्तक्षेप / उपचार
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

पात्रता मापदंड

युग अध्ययन के लिए पात्र	15 Years सेवा 15 Years
सेक्स अध्ययन के लिए पात्र	Female
स्वस्थ स्वयंसेवकों को स्वीकार करता है	हाँ
मानदंड	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

परिणाम

प्राथमिक परिणाम उपाय

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

माध्यमिक परिणाम उपाय

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

अन्य परिणाम उपाय

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

कीवर्ड

प्रदाह

सेल्यूलोज़

कामेल्या सीनेन्सीस्

camellia

सार