The aim of this study is to determine radio protective effect of royal jelly on ionizing radiation-induced DNA damage in human peripheral blood lymphocytes. In this quasi experimental study, men at the age of 20 to 45 year old would attend. All participants with a history of radiotherapy, chemotherapy and allergy to royal jelly would be excluded. 30 men admitted to Hazrat-e- Maryam fertility center would participate in our study. In this study each participant gives blood samples twice. First sampling, on admission to the fertility center. After first sampling each participant would start taking orally 1000 mg royal jelly per day for two weeks. Second sampling would happen after this period. In each sampling step, blood samples would be divided into two parts, pre-irradiated and post-irradiated, and all of them would be investigated regarding DNA damage by Comet Assay. Primary outcome measures are DNA tail length.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090819091N1
Registration date:2014-09-13, 1393/06/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-13, 1393/06/22
Registrant information
Name
Navid Rafat
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
monfared@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Bobol university of medical science . Hazrat-e Maryam Fertility Center (Mazandaran, Sari)
Expected recruitment start date
2015-02-04, 1393/11/15
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of radio protective effect of Royal Jelly on ionizing radiation-induced DNA damage in human peripheral blood lymphocytes
Public title
Radio protective effect of royal jelly against ionizing-radiation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: men; at the age of 20 to 45 year old; Exclusion criteria: having a history of cancer; autoimmune diseases; having allergy to bee sting, to honey, to royal jelly and pollen; having a history of smoking; radiotherapy; chemotherapy; nuclear medicine scan; antibiotic therapy during last three months before attending the study.
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Babol university of medical sciences
Street address
Babol university of medical sciences, Ganj afrooz Av, Babol, Mazandaran
City
Babol
Postal code
Approval date
2014-08-16, 1393/05/25
Ethics committee reference number
4447 30/ژ/پ
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
2
Description of health condition studied
Radiation exposure
ICD-10 code
Z58.4
ICD-10 code description
Exposure to radiation
3
Description of health condition studied
Ionizing radiation exposure
ICD-10 code
W88
ICD-10 code description
Exposure to ionizing radiation
Primary outcomes
1
Description
Lymphocyte DNA tail length
Timepoint
A)On admission B)Two weeks after oral administration of royal jelly
Method of measurement
Visual scoring of DNA tail
Secondary outcomes
1
Description
Sperm count in semen sample
Timepoint
A)On admission B)75 days after oral administration of royal jelly
Method of measurement
Hemocytometer
2
Description
Gamma radiation dose
Timepoint
A)On admission B)75 days after oral administration of royal jelly
Method of measurement
in Gy scale measured by gamma radiation dosimeter
3
Description
Sperm morphology in semen sample
Timepoint
A)On admission B)75 days after oral administration of royal jelly
Method of measurement
Hemocytometer
4
Description
Sperm motility in semen sample
Timepoint
A)On admission B)75 days after oral administration of royal jelly
Method of measurement
Hemocytometer
Intervention groups
1
Description
This is an quasi-experimental study just including intervention group. In this study each participant gives blood samples twice. First sampling, on admission to the fertility center. After first sampling each participant would start taking orally 1000 mg royal jelly per day for two weeks. Second sampling would happen after this two-week period. In each sampling step, blood samples would be divided into two parts,pre-irradiated and post-irradiated, and all of them would be investigated regarding DNA damage by Comet Assay.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat-e Maryam Fertility Center
Full name of responsible person
Dr. Maryam Shahidi(PhD of medical physics,embryologist/Assistant professor)
Street address
Hazrat-e Maryam Fertility Center, Pasdaran Blv, Imam square, Sari, Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Dr. Moghaddam nia
Street address
Babol university of medical sciences, Ganj afrooz Av, Babol, Mazandaran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol university of medical sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Hazrat-e Maryam Fertility Center
Full name of responsible person
Dr. Maryam Shahidi(PhD of medical physics,embryologist/Assistant professor)
Street address
Hazrat-e Maryam Fertility Center, Pasdaran Blv, Imam square, Sari, Mazandaran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hazrat-e Maryam Fertility Center
Proportion provided by this source
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
Babol university of medical sciences
Full name of responsible person
Dr. Ali Shabestani Monfared
Position
PhD of medical physics/Professor at Babol university of medical sciences
Other areas of specialty/work
Street address
Babol university of medical sciences, Ganj afrooz Av, Babol, Mazandaran
City
Babol
Postal code
Phone
+98 11 3528 9256
Fax
Email
monfared_ali@yahoo.commonfared1345@gmail.com
Web page address
www.mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran university of medical sciences
Full name of responsible person
Dr. Maryam Shahidi
Position
Radiology BS- Radiobiology MS student
Other areas of specialty/work
Street address
Mazandaran university of medical sciences, Begining of Vali-Asr highway, Imam square, Sari,Mazandaran
City
Sari
Postal code
Phone
+98 11 3334 3333
Fax
Email
shahidi_maryam@yahoo.cominfo@ivfsari.com
Web page address
http://mazums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Navid Rafat
Position
Radiology BS- Radiobiology MS student
Other areas of specialty/work
Street address
Babol university of medical sciences, Ganl afrooz Av, Babol, Mazandaran
City
Babol
Postal code
Phone
00
Fax
Email
Navidrafat@yahoo.com
Web page address
www.mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)