Effect of Green Tea on Treatment of Lupus

Ahvaz Jundishapur University of Medical Sciences68 enrolled

Overview

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.

noting

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Autoimmune Lupus Erythematosus, Systemic

Interventions

Eligibility

Sex: FEMALEMin age: 15 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

systemic lupus erythematous Disease Activity

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

Time frame: Three months after starting of intervention

Secondary Outcomes

measurement of some proinflammatory and anthropometric markers

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)

Time frame: At baseline and after three months of intervention

Health-Related Quality of Life

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