Effect of Green Tea on Treatment of Lupus

Study Overview
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Brief Summary
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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
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noting

Official Title
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The Effect of Green Tea Extract on Some Inflammatory Biomarkers(IL 6, IL1β,TNF α,CRP), Serum Total Antioxidant Capacity(TAC), MDA and Disease Activity in Patients With Systemic Lupus Erythematous

Conditions
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Autoimmune, Lupus Erythematosus, Systemic

Intervention / Treatment
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* Dietary Supplement: green tea extract
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: green tea extract<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo<br>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<br>* Patients in placebo group receive daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Three months after starting of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | At baseline and after three months of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disease activity