Protocol summary

Summary
The aim of study is to explore the probable positive effects of Lemon balm and Cinnamomum zeylanicum on the paint workers through measuring blood oxidative stress markers such as total antioxidant capacity (TAC), total thiol molecules (TTM), lipid peroxidation (LPO), myeloperoxidase (MPO), and DNA damage as the marker of genotoxicity. Male painter with age range 27-50 and the least 5 work history will be inclued the study. Individuals with chronic disease, alcohol consumption, antioxidant consumption, and/or under drug treatment, or exposure to toxic materials, radiation therapy, or substance abuse will be exclud from the study. The study will be perform on 27 male workers who work in an industrial and farm machinery producing company. The included subjectswill be administer Lemon balm and Cinnamon mixture infusion (1.5 and 0.25 g/100 mL) twice a day for 30 days at 7:00 AM and 2:00 PM every day. The Iranian version of General Health Questionnaire (GHQ28) will be use to single out high risk subjects for mental disorder, and the Iranian version of achievement motivation test (ACMT) and job satisfaction tests will be also use to evaluate achievement motivation and job satisfaction.To survey effect of infusion on oxidative stress, befor and after using mixture infusion blood sample will be collect.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013040610003N3
Registration date: 2013-04-22, 1392/02/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-04-22, 1392/02/02
Registrant information
Name
Ali akbar Malekirad
Name of organization / entity
Payame Noor University
Country
Iran (Islamic Republic of)
Phone
+98 86 2422 6073
Email address
malekirad@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Payame Noor University
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-05-31, 1392/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of psychological state, oxidative stress and genotoxicity before and after use of lemon balm and cinnamon in car painters
Public title
the effect of lemon balm and cinnamon on oxidative stress in paint workers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:age range 27-50;male;the least 5 work history;paint workers Exclusion Criteria: Individuals with chronic disease; alcohol consumption; antioxidant consumption; and/or under drug treatment; or exposure to toxic materials; radiation therapy; or substance abuse
Age
From 27 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 27
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Pharmaceutical Sciences Research Center, Tehran University of Medical Science
Street address
Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Tehran University of Medical Science, 16 Azar Street,Tehran 1417614411, Iran
City
Tehran
Postal code
Tehran 1417614411
Approval date
2012-07-15, 1391/04/25
Ethics committee reference number
91-01-21:1-3

Health conditions studied

1

Description of health condition studied
مواجهه شغلی
ICD-10 code
Z57.5
ICD-10 code description
Occupational exposure to toxic agents in other industries

Primary outcomes

1

Description
total antioxidant capacity of serum
Timepoint
before and 30 day after intervention
Method of measurement
Ferric Reducing Ability of Plasma method

2

Description
total thiol groups
Timepoint
before and 30 day after intervention
Method of measurement
Hu method

3

Description
lipid peroxidation
Timepoint
before and 30 day after intervention
Method of measurement
thiobarbitturic acid method

4

Description
Myleoperoxidase activity
Timepoint
before and 30 day after intervention
Method of measurement
Elisa Method

5

Description
deoxyribonucleic acid Damage
Timepoint
before and 30 day after intervention
Method of measurement
Elisa method

Secondary outcomes

1

Description
General Health
Timepoint
befor the intervention
Method of measurement
GHQ qeustionaire

Intervention groups

1

Description
The included subjectswill be administer Lemon balm and Cinnamon mixture decoction (1.5 and 0.25 g/100 mL) twice a day for 30 days at 7:00 AM and 2:00 PM every day.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hepco Company, Arak, Iran
Full name of responsible person
Ahmad Gogarzi
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Payame Noor University
Full name of responsible person
Mehdi Kiani
Street address
Amanipou Alley, Khoram Street, Payame Noor University
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payame Noor University
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
Payame Noor University
Full name of responsible person
Aliَ Akbar Malekirad
Position
PhD.assistant prof.
Other areas of specialty/work
Street address
Amanipour Alley, Khoram street
City
Arak
Postal code
Phone
+98 86 1223 5541
Fax
Email
ak_malekirad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Scienc
Full name of responsible person
Mohammad Abdollahi
Position
Prof. of Toxicology
Other areas of specialty/work
Street address
Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Tehran University of Medical Science, 16 Azar Street, Tehran 14176146411, Iran.
City
Tehran
Postal code
Phone
+98 21 6648 2703
Fax
Email
Mohammad@TUMS.Ac.Ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Ali Akbar Malekirad
Position
Assistant prof. of Physiology
Other areas of specialty/work
Street address
Amanipour Alley, khoram street, Arak, Iran
City
Arak
Postal code
Phone
+98 86 1223 5541
Fax
Email
ak_malekirad@yahoo.com
Web page address

Sharing plan

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