Protocol summary

Study aim
Investigation of the effect of ginger and sesame oils on resistance against frostbite in military personnel
Design
The study includes double-blinded randomized controlled interventional trials (phase 1). Participants will be randomly allocated into 3 groups (of 20 subjects each) including control, sesame and ginger groups.
Settings and conduct
The cold-protective effect of topical application of ginger and sesame oils will be investigated on forty-two young men (control, ginger and sesame groups) using cold-water immersion trials (12°C and 5°C water) in the physiology laboratory of Aja University of medical sciences. The study is double-blinded in which neither the researcher nor the participants know what they were getting. The subjects of the oil groups will be asked to rub the oils on their hands up to the wrist and wait for 5 minutes before the immersion. The index finger skin temperature, systolic and diastolic blood pressure, pulse rate, the beginning of the pain sensation, pain and thermal sensation will be recorded before and immediately after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male participants aged 18-30 year-old Exclusion criteria: Raynaud’s syndrome; peripheral vascular disease; inflammatory arthritis; heart diseases; high blood pressure; malignancy; previous hand or finger transplantation
Intervention groups
The subjects of the ginger and sesame oil groups will be asked to rub the oils on their hands up to the wrist. The control group receives no treatment.
Main outcome variables
Index finger skin temperature; systolic and diastolic blood pressure; pulse rate; the beginning of the pain sensation; pain sensation; thermal sensation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200102045988N1
Registration date: 2020-02-25, 1398/12/06
Registration timing: prospective

Last update: 2020-02-25, 1398/12/06
Update count: 0
Registration date
2020-02-25, 1398/12/06
Registrant information
Name
Seyed Mojtaba Kasaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3353 6365
Email address
mkasaee2819@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison of the effect of ginger and sesame oils on resistance against frostbite in military personnel
Public title
The effect of ginger and sesame oils on resistance against frostbite
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male volunteers aged 18-30 year-old
Exclusion criteria:
Raynaud’s syndrome Peripheral vascular disease Inflammatory arthritis Heart diseases High blood pressure Malignancy Previous hand or finger transplantation
Age
From 18 years old to 30 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation sequence will be generated using a computer program. In this software, a code will be assigned to each group (Zingiber oil, Sesame oil and Control) and sample size will be written. Randomization will be done in blocks of three. Since the generated sequence is produced by research assistant, the main researcher is not informed of the assigned codes to the groups. The generated codes will be written on papers, then concealed sequentially inside opaque lookalike containers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blinded in which neither the researcher nor the participants know about the received treatment. The research assistant, who generates the allocation sequence, will conceal the code of related intervention inside opaque lookalike containers. The participants will get into the study (block size 3). The first participant will randomly choose one of the containers. Then, the other two participants will do the same and choose between the left containers. After choosing one of the containers by the participant, research assistant will read the concealed intervention code inside the container. Then, research assistant will give the related intervention to the main researcher to try it on the participant.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Artesh University of Medical Sciences
Street address
Ethics committee of Artesh University of Medical Sciences, West Fatemi St., Etemadzadeh St., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-06-18, 1397/03/28
Ethics committee reference number
IR.AJAUMS.REC.1397.019

Health conditions studied

1

Description of health condition studied
The effect of ginger and sesame oils on resistance against frostbite
ICD-10 code
T33.521
ICD-10 code description
Superficial frostbite of right hand

Primary outcomes

1

Description
Index finger skin temperature
Timepoint
Before and immediately after intervention
Method of measurement
Infrared thermometer

2

Description
Systolic blood pressure
Timepoint
Before and immediately after intervention
Method of measurement
Digital sphygmomanometer

3

Description
Diastolic blood pressure
Timepoint
Before and immediately after intervention
Method of measurement
Digital sphygmomanometer

4

Description
Pulse rate
Timepoint
Before and immediately after intervention
Method of measurement
Digital sphygmomanometer

Secondary outcomes

1

Description
Beginning of the pain sensation
Timepoint
After intervention (during immersion)
Method of measurement
Stopwatch

2

Description
Pain sensation
Timepoint
At the end of the immersion
Method of measurement
Eleven-point scale

3

Description
Thermal sensation
Timepoint
At the end of the immersion
Method of measurement
nine-point scale

Intervention groups

1

Description
Intervention group 1: ginger oil (20 drops or 0.75 cc using a pipette) will be rubbed on the right hand before immersion in the cold water. Ginger oil extraction method: Standard protocol in traditional medicine using sesame oil
Category
Prevention

2

Description
Intervention group 2: sesame oil (20 drops or 0.75 cc using a pipette) will be rubbed on the right hand before immersion in the cold water. Manufacturer: Niri Organic Yazd Company
Category
Prevention

3

Description
Control group: immersion of the right hand in the cold water without application of the oils
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Artesh University of Medical Sciences
Full name of responsible person
Nafiseh Hosseini Yekta
Street address
West Fatemi St., Etemadzadeh St., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
Email
nhyekta@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Saeed Soleiman Meigooni
Street address
West Fatemi St., Etemadzadeh St., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
Email
dr.saeed.meigooni@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Kasaei
Position
Conscript
Latest degree
Master
Other areas of specialty/work
Marine Biology
Street address
No. 151, Farzaneh Alley, Shohadaye Gomnam Blvd., Rasht City
City
Rasht
Province
Guilan
Postal code
4155813717
Phone
+98 13 3353 6365
Fax
Email
mkasaee2819@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Kasaei
Position
Conscript
Latest degree
Master
Other areas of specialty/work
Marine Biology
Street address
No. 151, Farzaneh Alley, Shohadaye Gomnam Blvd., Rasht City
City
Rasht
Province
Guilan
Postal code
4155813717
Phone
+98 13 3353 6365
Fax
Email
mkasaee2819@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Kasaei
Position
Conscript
Latest degree
Master
Other areas of specialty/work
Marine Biology
Street address
No. 151, Farzaneh Alley, Shohadaye Gomnam Blvd., Rasht City
City
Rasht
Province
Guilan
Postal code
4155813717
Phone
+98 13 3353 6365
Fax
Email
mkasaee2819@gmail.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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