Effect of Green Tea on Treatment of Lupus
Primary Purpose
Autoimmune, Lupus Erythematosus, Systemic
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
green tea extract
placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Autoimmune focused on measuring disease activity
Eligibility 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
Sites / Locations
- Iran
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
green tea extract
Placebo
Arm 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.
Patients in placebo group received daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
measurement of some proinflammatory and anthropometric markers
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)
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
Full Information
NCT ID
NCT02875691
First Posted
May 28, 2016
Last Updated
August 18, 2016
Sponsor
Ahvaz Jundishapur University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02875691
Brief Title
Effect of Green Tea on Treatment of Lupus
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahvaz Jundishapur University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
noting
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune, Lupus Erythematosus, Systemic
Keywords
disease activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
green tea extract
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in placebo group received daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months
Intervention Type
Dietary Supplement
Intervention Name(s)
green tea extract
Intervention Description
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
Intervention Name(s)
placebo
Intervention Description
Patients in placebo group receive daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months
Primary Outcome Measure Information:
Title
systemic lupus erythematous Disease Activity
Description
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
Time Frame
Three months after starting of intervention
Secondary Outcome Measure Information:
Title
measurement of some proinflammatory and anthropometric markers
Description
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)
Time Frame
At baseline and after three months of intervention
Title
Health-Related Quality of Life
Description
Quality of Life will be assessed by12-item Short-Form (SF-12v2) self-report questionnaire ,at baseline and after3 months of intervention
Time Frame
At baseline and after three months of intervention
Other Pre-specified Outcome Measures:
Title
Dietary intake
Description
24-Hour dietary recalls questionnaires will be used to assess dietary pattern
Time Frame
at baseline and after 3 month of intervention
Title
Weight
Description
Weight will be measured in kg
Time Frame
at baseline and after 3 month of intervention
Title
BMI
Description
BMI is weight in kilograms divided to height in meters squared
Time Frame
at baseline and after 3 month of intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iran Ahvaz
Organizational Affiliation
Ahvaz University of Medical Sceinces, Ahvaz, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iran
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Green Tea on Treatment of Lupus
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