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IRCT20200525047565N2 IRCT 2021-01-03 Shahid Beheshti University of Medical Sciences Comparative study of the effect of capsules "Ginger-Lavender", "Ginger" with "Mefenamic Acid " on the severity of primary dysmenorrhea Comparative study of the effect of capsules "Ginger-Lavender" ,"Ginger" with "Mefenamic Acid " on the severity of primary dysmenorrhea 2020-08-09 anticipated 90 Complete https://irct.ir/trial/49273 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, sampling is selected based on the number of targets from the single girl living in the dormitory.After introducing herself, the researcher will explain to the participants the goals and how to implement the research.Then, out of 90 students with study characteristics who have primary dysmenorrhea, they are placed in separate blocks (moderate and severe dysmenorrhea).In the next stage, people with moderate to severe pain are divided into three equal groups of capsule users"Ginger - Lavender" "Ginger" and" Mefenamic Acid " by accidental assignment using Excel software, Blinding description: The blinding was done in such a way that the capsule containing Ginger-Lavender and capsule containing Ginger was prepared in exactly the same way as the Mefenamic Acid capsule and coded.Only the Pharmacogenesis Consultant is aware of its contents and codes, and the researcher and participants in the research and data analyser are unaware of it.In this way, the study will be done in triple blind ways. 3 primary dysmenorrhea. Intervention 1: Intervention group: "Ginger-Lavender" group500 mg capsules containing 250 mg of ginger and 250 mg of lavender prepared in Shahid Beheshti School of Traditional Medicine will be used 4 times a day (once every 6 hours) from the beginning of menstruation until the third day. Basic pain (before the intervention) is measured with the help of a pain ruler, then during the two intervention periods, the relevant questionnaire (pain ruler) will be given to the sample, and at the end, the average pain at the end of every three days will be estimated. Intervention 2: Intervention group: "Ginger" group will use 250 mg "Ginger" capsule prepared in Shahid Beheshti School of Traditional Medicine 4 times (once every 6 hours) from the beginning of menstruation until the third day. The pain reliever is measured, then during the two intervention periods, the relevant questionnaire (pain reliever) will be given to the sample, and at the end, the average pain at the end of every three days will be estimated. Intervention 3: "Mefenamic Acid" group will use Amin Company's 250 mg "Mefenamic Acid" capsule 4 times a day (every 6 hours) from the beginning of menstruation until the third day. Basic pain (before intervention) is measured with the help of a pain ruler. Then, during the two intervention periods, the relevant questionnaire (pain ruler) will be given to the sample and at the end, the average pain at the end of every three days will be estimated. No - There is not a plan to make this available Justification or reason for not sharing IPD is The data remains confidential to the researcher at first
public Sharareh Jannesari
Schoole of Nursing and Midwifery, Opposite to Rajaee Heart Hospital, Vali-Asr Avenue, Intersection Vali-Asr and Neiaiesh Highway, Tehran, Iran .
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 shararehjannesari@gmail.com Shahid Beheshti University of Medical Sciences scientific Sharareh Jannesari
Schoole of Nursing and Midwifery, Valiasr Street, Intersection of Niayesh Highway,Tehran, Iran .
Tehran Iran (Islamic Republic of) 1996835119 0218855366 shararehjannesari@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 1)Be 18 to 30 years old and single. 2)Experience menstrual pain in the first 3 days of bleeding for 3 consecutive periods in the last 6 months 3)People with primary dysmenorrhea whose pain intensity is moderate to severe according to McGill's pain ruler 4)Not known to be a person with a chronic illness (diabetes, high blood pressure, cardiovascular, infectious, liver, and epilepsy) 5)Do not have a specific gynecological disease that interferes with the study process 6)Have regular cycles with intervals of 21 to 38 days and the duration of menstruation is 3-7 days 7)Their body mass index is in the normal range of 19.8 to 26 8)According to the person, there are no symptoms such as burning, itching or abnormal discharge during the study. 9)Do not take any medications or supplements. 10)No herbal medicine has been used for 3 months before the intervention.01 11)Stressful factors such as parental separation, death of first-degree relatives, etc. should not be present in the last six months 18 years 35 years Female 1)Dissatisfaction or obedience of the person to continue participating in the study 2)Lack of proper use of medication or mefenamic acid 3)Take any herbal medicine while studying N94.4 Primary dysmenorrhoea Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: "Ginger-Lavender" group500 mg capsules containing 250 mg of ginger and 250 mg of lavender prepared in Shahid Beheshti School of Traditional Medicine will be used 4 times a day (once every 6 hours) from the beginning of menstruation until the third day. Basic pain (before the intervention) is measured with the help of a pain ruler, then during the two intervention periods, the relevant questionnaire (pain ruler) will be given to the sample, and at the end, the average pain at the end of every three days will be estimated. Intervention group: "Ginger" group will use 250 mg "Ginger" capsule prepared in Shahid Beheshti School of Traditional Medicine 4 times (once every 6 hours) from the beginning of menstruation until the third day. The pain reliever is measured, then during the two intervention periods, the relevant questionnaire (pain reliever) will be given to the sample, and at the end, the average pain at the end of every three days will be estimated. "Mefenamic Acid" group will use Amin Company's 250 mg "Mefenamic Acid" capsule 4 times a day (every 6 hours) from the beginning of menstruation until the third day. Basic pain (before intervention) is measured with the help of a pain ruler. Then, during the two intervention periods, the relevant questionnaire (pain ruler) will be given to the sample and at the end, the average pain at the end of every three days will be estimated. Severity of primary dysmenorrhea. Timepoint: End of the third day of the cycle before the intervention, end of the third day of the first cycle and second cycle after the intervention. Method of measurement: Visual analog scale. Systematic symptoms. Timepoint: End of the third day of the cycle before the intervention, end of the third day of the first cycle and second cycle after the intervention. Method of measurement: Verbal rating scale. Shahid Beheshti University of Medical Sciences Approved 2019-12-09 Ethics Committee In Research, School of Farmecy, Nurssing, Midwifery of Shahid Beheshti University. Schoole of Nursing and Midwifery, Opposite to Rajaee Heart Hospital, Valiasr Street, Intersection of Niayesh Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)