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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

Protocol summary

Summary
Aim of this study is to determine and compare the efficacy of green tea extract on inflammatory markers including IL 1β, IL 6, CRP, TNF α, total antioxidant capacity (TAC), MDA and severity of the disease in lupus patients in two groups of intervention and control . This study is a randomized, double-blind clinical trial. The subjects are systemic lupus erythematous patients. This study is in the second phase of clinical trial. The subjects are patients older than 15 years who have had 4 diagnosis criteria’s of lupus. These include clinical and immunological criteria's. Study participants were randomly divided into 2 groups of intervention( capsules of green tea extract) and control group (capsule of cellulose). Exclusion criteria are as follow: patients with other autoimmune diseases; infectious or liver disease; patients with creatinine higher than 2.5 and the women who are pregnant. The sample were found to be 76. The patients in intervention group are 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 are given daily dose of 1000mg of cellulose in form of two capsules ( 500 mg). Duration of treatment is three months. Measured variables at baseline and after 12 weeks include Inflammatory factors ( IL 6, IL 1β , TNF α), CRP, MDA, serum total antioxidant capacity(TAC) and disease activity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091924059N2
Registration date: 2016-02-20, 1394/12/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-20, 1394/12/01
Registrant information
Name
Zahra Shamekhi
Name of organization / entity
Ahvaz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8253
Email address
shamekhi.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific 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
Public title
Effect of green tea on treatment of lupus
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria : patients older than 15 years who have had 4 diagnosis criteria’s of lupus. These include clinical and immunological criteria. Exclusion criteria: patients with other autoimmune diseases; infectious or liver disease; patients with creatinine higher than 2.5 and women who are pregnant.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In randomized , table of random numbers was used.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Ahvaz University of Medical Sceinces
Street address
Vice chancellor for research of Ahvaz University of Medical Sceinces, golestan highway, Ahvaz, Iran
City
Ahvaz
Postal code
61357,15794
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.AJUMS.REC.1394.251

Health conditions studied

1

Description of health condition studied
Systemic lupus erythmatous
ICD-10 code
M32.9
ICD-10 code description
Systemic Lupus Erythematosus, unspecified

Primary outcomes

1

Description
Disease Activity
Timepoint
Three months after starting of intervention
Method of measurement
Determination of disease activity is done through SLEDAI ( systemic lupus erythmatous disease activity index ) questionnare.

Secondary outcomes

1

Description
(IL6,IL1β, TNFα,CRP),MDA ,serum total antioxidant capacity
Timepoint
At baseline and after three months of intervention
Method of measurement
Comparison of variables of each group before and after intervention

Intervention groups

1

Description
Intervention group: 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.
Category
Treatment - Drugs

2

Description
Control group : Patients in Control group receive daily dose of 1000 mg cellulose in the form of 2 capsules ( 500 mg) for three months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Lupus clinic, Hafez hospital, Shiraz University of Medical Sceinces
Full name of responsible person
Zahra Shamekhi
Street address
Lupus clinic, Hafez hospital, Shiraz University of Medical Sceinces,Abivedi street,Shiraz, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research , Ahvaz university of medical sceinces
Full name of responsible person
Zahra Shamekhi
Street address
Ahvaz University of medical sciences, golestan high way, Ahvaz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research , Ahvaz university of medical sceinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz university of medical sceinces
Full name of responsible person
Zahra Shamekhi
Position
Ph.D student
Other areas of specialty/work
Street address
Ahvaz University of Medical Sceinces, Ahvaz, Iran
City
Ahvaz
Postal code
Iran
Phone
+98 61 3336 1984
Fax
Email
zshamekhi2007@gmail.com;z_shamekhi2007@yahoo.com;shamekhi.z@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sceinces
Full name of responsible person
Zahra Shamekhi
Position
Ph.D student
Other areas of specialty/work
Street address
University of Medical Sceinces, Ahvaz,Iran
City
Ahvaz
Postal code
Phone
+98 71 3620 0251
Fax
Email
zshamekhi2007@gmail .com; z_shamekhi2007@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sceinces
Full name of responsible person
Zahra Shamekhi
Position
Ph.D student
Other areas of specialty/work
Street address
University of Medical sceinces , Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 71 3620 0251
Fax
Email
zshamekhi2007@gmail .com; z_shamekhi2007@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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