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| ID | Type | Description | Link |
|---|---|---|---|
| IR.AJUMS.REC.1394.251 | Other Identifier | Ahvaz Jundishapur University of Medical Sciences |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| green tea extract | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | Patients in placebo group received daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| green tea extract | Dietary Supplement | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary intake | 24-Hour dietary recalls questionnaires will be used to assess dietary pattern | at baseline and after 3 month of intervention |
| Weight | Weight will be measured in kg |
Inclusion Criteria:
The patients older than 15 years,diagnosed with systemic lupus erythematous (SLE) according to ACR(American College of Rheumatology) criteria.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iran Ahvaz | Ahvaz University of Medical Sceinces, Ahvaz, Iran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iran | Shiraz | Fars | Iran |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| placebo | Dietary Supplement | Patients in placebo group receive daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months |
|
| 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 |
| at baseline and after 3 month of intervention |
| BMI | BMI is weight in kilograms divided to height in meters squared | at baseline and after 3 month of intervention |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |