Assessment of anti-oxidant and anti-inflammatory properties of green tea hydroalcoholic extract on oxidative-stress factors in patients with pneumonia hospitalized at ICU in Ziaeian teaching hospital
In order to find an efficient anti-oxidant and evaluate anti-oxidant property of green tea we decided to use it in critically ill pneumonia patients with SIRS. In this study dried green tea is bought from Lahijan, Iran. Tea leaves are grinded, extracted by hydro alcoholic solvent and then dried. Extract standardization based on poly phenolic content performed by Total phenolic assay and total antioxidant power. Twenty ICU patients are divided randomly in two groups. As a single blind study, Group one will receive standardized extract containing 130 milligrams of poly phenol and group two will receive placebo, both groups three times a day at 8 AM, 2 PM and 8 PM for one week. Blood sample will be taken on day 0 before administration, days 3 and 7 after five hours from the last administration. Total thiol, total anti-oxidant power and IL-6 plasma levels will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092529327N2
Registration date:2016-10-25, 1395/08/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-25, 1395/08/04
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Pharmaceutical Science, Investigator
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2017-04-01, 1396/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of anti-oxidant and anti-inflammatory properties of green tea hydroalcoholic extract on oxidative-stress factors in patients with pneumonia hospitalized at ICU in Ziaeian teaching hospital
Public title
Assessment of anti-oxidant and anti-inflammatory properties of green tea in ICU patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ICU admission less than 1 week ; SIRS positive ; APACHE Score higherthan 10 ; Pneumonia diagnosis ; Tea consumption history
Exclusion criteria : being NPO ; pregnancy ; age less than 18 years
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Pharmaceutical Sciences
Street address
#99, Yakhchal Ave., Shariati st.
City
Tehran
Postal code
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.IAU.PS.REC.1395.6
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J15, J14,
ICD-10 code description
Pneumonia due to Streptococcus pneumoniae, Pneumonia due to Haemophilus influenzae, Bacterial pneumonia, not elsewhere classified
Primary outcomes
1
Description
Total anti-oxidant power
Timepoint
Day 0, 3, 7
Method of measurement
FRAP
2
Description
Total plasma thiol
Timepoint
Day 0, 3, 7
Method of measurement
Ellman method
3
Description
interleukin 6
Timepoint
Day 0, 7
Method of measurement
ELISA
Secondary outcomes
1
Description
lenth of stay
Timepoint
at the end of the study
Method of measurement
mathematical
2
Description
mechanical ventilation days
Timepoint
at the end of the study
Method of measurement
mathematical
3
Description
APACHE II score
Timepoint
day 0,7
Method of measurement
medical calculator
Intervention groups
1
Description
Intervention group will receive standardized extract containing 130 milligrams of poly phenol three times a day at 8 AM, 2 PM and 8 PM for one week
Category
Treatment - Drugs
2
Description
Control group will receive placebo three times a day at 8 AM, 2 PM and 8 PM for one week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Zohre Labbani Motlagh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Pharmaceutical Science
Full name of responsible person
zohre Labbani Motlagh
Street address
#99, Yakhchal Ave, Shariati st.
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Pharmaceutical Science
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
Islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Other areas of specialty/work
Street address
#99, Yakhchal Ave, Shariati st.
City
Tehran
Postal code
Phone
+98 21 6393 5258
Fax
Email
r_abrishami@iaups.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Other areas of specialty/work
Street address
#99, Yakhchal Ave, Shariati st.
City
Tehran
Postal code
Phone
+98 21 6393 5258
Fax
Email
r_abrishami@iaups.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Ramin Abrishami
Position
Assistant Professor
Other areas of specialty/work
Street address
#99, Yakhchal Ave., Shariati St.
City
Tehran
Postal code
Phone
+98 21 6393 5258
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)