Effect of Green Tea on Treatment of Lupus

Ahvaz Jundishapur University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Lupus Erythematosus, Systemic; Autoimmune

Treatments: Dietary Supplement: placebo; Dietary Supplement: green tea extract

Study type: Interventional

Funder types: Other

Identifiers

NCT02875691

IR.AJUMS.REC.1394.251 (Other Identifier)

Details and patient eligibility

About

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.

Full description

noting

Enrollment: 68 patients

Sex: Female

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

green tea extract

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: green tea extract

Placebo

Placebo Comparator group

Description:

Patients in placebo group received daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months

Treatment:

Dietary Supplement: placebo