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IRCT20201010048979N3 IRCT 2022-05-06 Tehran University of Medical Sciences The effect of topical pads containing ginger oil on dysmenorrhea Evaluation effectiveness of topical ginger oil pad in dysmenorrhea: Triple blind-placebo-controlled Randomized Clinical Trial 2022-05-22 anticipated 30 Complete https://irct.ir/trial/62803 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study subjects are assigned to one of the intervention and control groups by Permuted Block Randomization method by random sampling method from one of the numbers 1 to 6 using SPSS software. Numbers 1 to 6 are specific codes of each sequence BBAA, AABB, ABAB, BABA ABBA, BAAB. according on selected sequence, each group of four-subject receives one of the intervention and control methods, Blinding description: The medicine and placebo group will receive similar pads in shape and size and in the same packages labeled with codes A and B. The patient and the researcher prescribing the drug and analyzing the data are not aware of the meaning of the codes. The results of the study are reviewed by a researcher who is not aware of the grouping and is blind to the groups and the type of drug. 3 Primary dysmenorrhea. Intervention 1: Intervention group: Each eligible patient will receive three topical pads containing ginger oil in each two menstrual cycles and a new pad will be replaced every 48 hours. the pad will be located on the abdomen under umbilicus and above the pubic area. If They have pain for a maximum of one hour after using the pad, they can take one mefenamic acid capsule. The number of capsules allowed per day is 2 and the number of capsules consumed is recorded per cycle. Intervention 2: Control group: Each eligible patient will receive three placebo pads in each two menstrual cycles and a new pad will be replaced every 48 hours. the pad will be located on the abdomen under umbilicus and above the pubic area. If They have pain for a maximum of one hour after using the pad, they can take one mefenamic acid capsule. The number of capsules allowed per day is 2 and the number of capsules consumed is recorded in per cycle. 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 There is no more information
public Leila Shirbeigi
No.27, School of Traditional Medicine, Sarparast St., Taleghani Ave.
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8899 3656 l.shirbeigi@yahoo.com Tehran University of Medical Sciences scientific Leila Shirbeigi
No.27, School of Traditional Medicine, Sarparast St., Taleghani Ave.
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8899 3656 l.shirbeigi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Women aged 15 to 45 years old BMI(body mass index)≤35 Regular menstruation at intervals of 21 to 35 days and regular bleeding for 3 to 10 days at least in the last 3 months Moderate and severe dysmenorrhea (based on Multidimensional Verbal Scoring System ) 15 years 45 years Female Pregnancy History of secondary dysmenorrhea History of abdominal or pelvic surgery Taking other medications History of skin allergies to ginger N94.4 Primary dysmenorrhea Treatment - Drugs Placebo Intervention group: Each eligible patient will receive three topical pads containing ginger oil in each two menstrual cycles and a new pad will be replaced every 48 hours. the pad will be located on the abdomen under umbilicus and above the pubic area. If They have pain for a maximum of one hour after using the pad, they can take one mefenamic acid capsule. The number of capsules allowed per day is 2 and the number of capsules consumed is recorded per cycle. Control group: Each eligible patient will receive three placebo pads in each two menstrual cycles and a new pad will be replaced every 48 hours. the pad will be located on the abdomen under umbilicus and above the pubic area. If They have pain for a maximum of one hour after using the pad, they can take one mefenamic acid capsule. The number of capsules allowed per day is 2 and the number of capsules consumed is recorded in per cycle. Pain intensity. Timepoint: cycle before intervention, every cycles during intervention (2 cycles). Method of measurement: VAS (visual analog scale). Pain duration. Timepoint: cycle before intervention, every cycles during intervention (2 cycles). Method of measurement: hour. Patient satisfaction with treatment. Timepoint: every cycles during intervention (2 cycles). Method of measurement: questionnaire. Physician satisfaction with treatment. Timepoint: every cycles during intervention (2 cycles). Method of measurement: questionnaire. Drug side effects. Timepoint: every cycle during the intervention (2 cycles). Method of measurement: questionnaire. Mefenamic acid consumption. Timepoint: cycle before intervention, every cycles during intervention (2 cycles). Method of measurement: number. Tehran University of Medical Sciences Approved 2022-03-16 Ethics committee of Tehran University of Medical Sciences 1th Floor, Medicine School, Poursina St, Qods St, Enghelab St. Tehran Tehran Iran (Islamic Republic of)