Effect of Green Tea on Treatment of Lupus

Phase 2

Completed

• Conditions: Autoimmune; Lupus Erythematosus, Systemic
• Interventions: Dietary Supplement: green tea extract; Dietary Supplement: placebo

• Registration Number: NCT02875691
• Lead Sponsor: Ahvaz Jundishapur University of Medical Sciences

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

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Study First Submitted: 2016-05-28
• Study First Submitted QC: 2016-08-18
• Last Update Submitted: 2016-08-18
• Study First Posted: 2016-08-23
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
green tea extract	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.
Placebo	placebo	Patients in placebo group received daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Iran; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of