Autoimmune, Lupus Erythematosus, Systemic
Conditions
Keywords
disease activity
Brief summary
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.
Detailed description
noting
Interventions
DIETARY_SUPPLEMENTgreen 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.
DIETARY_SUPPLEMENTplacebo
Patients in placebo group receive daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months
Sponsors
Ahvaz Jundishapur University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dietary intake | at baseline and after 3 month of intervention | 24-Hour dietary recalls questionnaires will be used to assess dietary pattern |
| Weight | at baseline and after 3 month of intervention | Weight will be measured in kg |
| BMI | at baseline and after 3 month of intervention | BMI is weight in kilograms divided to height in meters squared |
Countries
Iran
Outcome results
None listed