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NCT Number: NCT02875691

Effect of Green Tea on Treatment of Lupus

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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Key information

Conditions

Autoimmune Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Iran

Shiraz, Fars, Iran

About this study

noting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

Other outcomes

  1. Dietary intake

    Time frame: at baseline and after 3 month of intervention

    24-Hour dietary recalls questionnaires will be used to assess dietary pattern

  2. Weight

    Time frame: at baseline and after 3 month of intervention

    Weight will be measured in kg

  3. BMI

    Time frame: at baseline and after 3 month of intervention

    BMI is weight in kilograms divided to height in meters squared

Sponsors and collaborators

Lead sponsor

Ahvaz Jundishapur University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 23, 2016
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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