Effect of Green Tea on Treatment of Lupus

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

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.

Study Overview

• Status: Completed
• Conditions: Lupus Erythematosus, Systemic; Autoimmune
• Intervention / Treatment: Dietary supplement: green tea extract; Dietary supplement: placebo

Detailed Description

noting

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Iran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ahvaz Jundishapur University of Medical Sciences
• Investigators: Principal Investigator: Iran Ahvaz, Ahvaz University of Medical Sceinces, Ahvaz, Iran

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 28, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimate): August 23, 2016

Study Record Updates

• Last Update Posted (Estimate): August 23, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: disease activity
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: IR.AJUMS.REC.1394.251 (Other Identifier: Ahvaz Jundishapur University of Medical Sciences)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided