Effect of Green Tea on Treatment of Lupus

Lupus Erythematosus, Systemic Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875691
• Other study ID #: IR.AJUMS.REC.1394.251
• Secondary ID: IR.AJUMS.REC.139
• Status: Completed
• Phase: Phase 2
• First received: May 28, 2016
• Last updated: August 18, 2016
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Ahvaz Jundishapur University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

noting

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Autoimmune
• Lupus Erythematosus, Systemic

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Iran	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Ahvaz Jundishapur University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary intake	24-Hour dietary recalls questionnaires will be used to assess dietary pattern	at baseline and after 3 month of intervention	Yes
Other	Weight	Weight will be measured in kg	at baseline and after 3 month of intervention	Yes
Other	BMI	BMI is weight in kilograms divided to height in meters squared	at baseline and after 3 month of intervention	Yes
Primary	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	Yes
Secondary	measurement of some proinflammatory and anthropometric markers	interleukin-6 (IL6), interleukin1ß(IL1ß , Tumor Necrosis Factor-a (TNF-a),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	Yes
Secondary	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	Yes