Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Green Tea on Treatment of Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02875691
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
zahra shamekhi, Ahvaz Jundishapur University of Medical Sciences

Brief 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.


Condition or disease Intervention/treatment Phase
Autoimmune Lupus Erythematosus, Systemic Dietary Supplement: green tea extract Dietary Supplement: placebo Phase 2

Detailed Description:
noting

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875691


Locations
Layout table for location information
Iran, Islamic Republic of
Iran
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Ahvaz Jundishapur University of Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: Iran Ahvaz Ahvaz University of Medical Sceinces, Ahvaz, Iran
Layout table for additonal information
Responsible Party: zahra shamekhi, zahra shamekhi , phd student in Ahvaz Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02875691    
Other Study ID Numbers: IR.AJUMS.REC.1394.251
IR.AJUMS.REC.1394.251 ( Other Identifier: Ahvaz Jundishapur University of Medical Sciences )
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by zahra shamekhi, Ahvaz Jundishapur University of Medical Sciences:
disease activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases