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Evaluation of the effect of capsules containing natural products on serum level of biomarkers related to air pollution

Protocol summary

Study aim
Comparison of the effect of 250 mg and 500 mg air pollution capsules on changes in serum levels of glutathione peroxidase, total antioxidant, CRP, fibrinogen, WBC, hematocrit and blood pressure in the control and treatment groups
Design
Clinical trial with control group, parallel groups, double blind and randomized, phase 3. Sample size will be equal to 90
Settings and conduct
The study will be carried out on military staffs in Tehran who are exposed to air pollution. Subjects will be randomly divided into three groups (500,and 250 mg air capsules and placebo) The capsules are given in two phases, each phase for 3 weeks, The study design is a way that executive agents, samples, and statistics experts do not know the contents of the capsules in each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria include occupational activity of at least one year in central Tehran, ages 21 to 60 years and no significant internal disease. Exclusion criteria included developing a drug allergic reaction during the study and not taking the intervention (less than 5 weeks after beginning the study).
Intervention groups
The subjects will be assigned into three groups: group 1 (intervention) 500 mg air pollution capsule, group 2 (intervention) 250 mg air pollution capsule and group 3 (Control) placebo capsules.
Main outcome variables
The effect of an Iranian medicine product on the health complications of air pollution

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180611040053N2
Registration date: 2020-02-23, 1398/12/04
Registration timing: prospective

Last update: 2020-02-23, 1398/12/04
Update count: 0
Registration date
2020-02-23, 1398/12/04
Registrant information
Name
Mohammad Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 4484
Email address
mghmed@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of capsules containing natural products on serum level of biomarkers related to air pollution
Public title
Evaluation of the effect of a functional capsule on the complications of air pollution
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Signing informed consent working for more than 1 year in central regions in Tehran age between 21-60 years No significant renal or hepatic or pulmonary disease No hyperthyroidism No smoking or addiction to any drugs No cardiovascular diseases No consuming antioxidant medications or supplements No current fissures and hemorrhoids
Exclusion criteria:
history of sensitivity to herbal medications
Age
From 21 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects in the study will be randomly divided into three groups. In this case first 5 triad blocks (letters A, B and C) will be made up for each six possible conditions (totally 30 blocks).These blocks will then be randomly selected and grouped together.So individuals will be allocated to the groups according each selected letter,.
Blinding (investigator's opinion)
Single blinded
Blinding description
Individuals in all three groups will receive capsules of the same shape, size, and packaging. But on each package according to the type of capsules will be written; Model 1, Model 2 and Model 3 and the content of each model will be kept with the project supervisor so the presenters, study subjects and statistics expert will not be aware of the contents of the capsules.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ٍEthics Committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Molla Sadra street, Sheikh Bahaee street, Shahid Nosrati avenue
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.BMSU.REC.1397.347

Health conditions studied

1

Description of health condition studied
medical effects of air pollution
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum levels of gluthation peroxidase, total antioxidant, CRP, fibrinogen, WBC and hematocrit
Timepoint
Two times, before the intervention and six weeks after beginning the intervention
Method of measurement
medical laboratory

Secondary outcomes

1

Description
Blood pressure
Timepoint
Two times, before the intervention and six weeks after beginning the intervention
Method of measurement
Mercury sphygmomanometer

Intervention groups

1

Description
ّFirst intervention group: Administration of Weba air 500 milligram capsule containing processed saffron powder, patience yellow and cream produced by Barij Essence Company Two capsules will be consumed three times a week half hours before meal for 6 weeks.
Category
Prevention

2

Description
Second intervention group: Administration of Weba air 250 milligram capsule containing processed saffron powder, patience yellow and cream produced by Barij Essence Company Two capsules will be consumed three times a week half hours before meal for 6 weeks.
Category
Prevention

3

Description
Control group: Administration of placebo capsule produced by Barij Essence Company Two capsules are consumed three times a week half hours before a meal for 6 weeks
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences
Full name of responsible person
Gholamhossein Pourtaghi
Street address
Baqiyatallah University of Medical Sciences, Shahid Nosrati ave, Sheikh Bahaaee street, Molla Sadra street,
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4484
Fax
+98 21 8860 0062
Email
mghmed@bmsu.ac.ir
Web page address
https://www.irct.ir/user/trial/41826/update/recruitment_center

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Barij Essense Company
Full name of responsible person
Leila Mohammad Taghizadeh
Street address
Kashan- Delijan road (kilometer 44)
City
Kashan
Province
Isfehan
Postal code
3795191916
Phone
+98 86 4446 5112
Fax
+98 86 4446 5112
Email
ghpourtaghi@yahoo.com
Web page address
http://barijessence.com/
Grant name
Research credit
Grant code / Reference number
97000263
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essense Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Barij Essense
Full name of responsible person
Leila Mohammad Thaghizadeh
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Number 78, Marzdaran street
City
Tehran
Province
Tehran
Postal code
3795191916
Phone
+98 21 4426 7992
Fax
+98 21 4426 7992
Email
gpourtaghi@yahoo.com
Web page address
http://barijessence.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Ghasemi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Occupational Medicine
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahaaee street, Molla Sadra street,
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4484
Fax
+98 21 8860 0062
Email
mghmed@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholam Hossein Pourtaghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Health
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahaaee street, Molla Sadra street,
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4484
Fax
+98 21 8860 0062
Email
gpourtaghi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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