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IRCT20200102045988N1 IRCT 2020-02-25 Artesh University of Medical Sciences The effect of ginger and sesame oils on resistance against frostbite Investigation and comparison of the effect of ginger and sesame oils on resistance against frostbite in military personnel 2020-03-05 anticipated 60 Complete https://irct.ir/trial/44746 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 The effect of ginger and sesame oils on resistance against frostbite. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: immersion of the right hand in the cold water without application of the oils. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information available
public Seyed Mojtaba Kasaei
No. 151, Farzaneh Alley, Shohadaye Gomnam Blvd., Rasht City
Rasht Iran (Islamic Republic of) 4155813717 +98 13 3353 6365 mkasaee2819@gmail.com Artesh University of Medical Sciences scientific Seyed Mojtaba Kasaei
No. 151, Farzaneh Alley, Shohadaye Gomnam Blvd., Rasht City
Rasht Iran (Islamic Republic of) 4155813717 +98 13 3353 6365 mkasaee2819@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) Male volunteers aged 18-30 year-old 18 years 30 years Male Raynaud’s syndrome Peripheral vascular disease Inflammatory arthritis Heart diseases High blood pressure Malignancy Previous hand or finger transplantation T33.521 Superficial frostbite of right hand Prevention Prevention Prevention 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 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 Control group: immersion of the right hand in the cold water without application of the oils Index finger skin temperature. Timepoint: Before and immediately after intervention. Method of measurement: Infrared thermometer. Systolic blood pressure. Timepoint: Before and immediately after intervention. Method of measurement: Digital sphygmomanometer. Diastolic blood pressure. Timepoint: Before and immediately after intervention. Method of measurement: Digital sphygmomanometer. Pulse rate. Timepoint: Before and immediately after intervention. Method of measurement: Digital sphygmomanometer. Beginning of the pain sensation. Timepoint: After intervention (during immersion). Method of measurement: Stopwatch. Pain sensation. Timepoint: At the end of the immersion. Method of measurement: Eleven-point scale. Thermal sensation. Timepoint: At the end of the immersion. Method of measurement: nine-point scale. Artesh University of Medical Sciences Approved 2018-06-18 Ethics committee of Artesh University of Medical Sciences Ethics committee of Artesh University of Medical Sciences, West Fatemi St., Etemadzadeh St., Tehran Tehran Tehran Iran (Islamic Republic of)