Effect of Green Tea on Treatment of Lupus

NCT ID: NCT02875691

Last Updated: 2016-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-03-31

Brief Summary

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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

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noting

Conditions

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Autoimmune Lupus Erythematosus, Systemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

green tea extract

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ahvaz Jundishapur University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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zahra shamekhi

zahra shamekhi , phd student in Ahvaz Jundishapur University of Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iran Ahvaz

Role: PRINCIPAL_INVESTIGATOR

Ahvaz University of Medical Sceinces, Ahvaz, Iran

Locations

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Iran

Shiraz, Fars, Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.AJUMS.REC.1394.251

Identifier Type: OTHER

Identifier Source: secondary_id

IR.AJUMS.REC.1394.251

Identifier Type: -

Identifier Source: org_study_id

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