Effect of Green Tea on Treatment of Lupus
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|ClinicalTrials.gov Identifier: NCT02875691|
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : August 23, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Lupus Erythematosus, Systemic||Dietary Supplement: green tea extract Dietary Supplement: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
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
- systemic lupus erythematous Disease Activity [ Time Frame: 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
- measurement of some proinflammatory and anthropometric markers [ Time Frame: 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 [ Time Frame: 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
- Dietary intake [ Time Frame: at baseline and after 3 month of intervention ]24-Hour dietary recalls questionnaires will be used to assess dietary pattern
- Weight [ Time Frame: at baseline and after 3 month of intervention ]Weight will be measured in kg
- BMI [ Time Frame: at baseline and after 3 month of intervention ]BMI is weight in kilograms divided to height in meters squared
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875691
|Iran, Islamic Republic of|
|Shiraz, Fars, Iran, Islamic Republic of|
|Principal Investigator:||Iran Ahvaz||Ahvaz University of Medical Sceinces, Ahvaz, Iran|