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IRCT20230315057729N1 IRCT 2023-05-31 Mashhad University of Medical Sciences The effect of hydroalcoholic extract of coriander seed on primary dysmenorrhea The effect of hydroalcoholic extract of coriander seed on primary dysmenorrhea 2023-06-10 anticipated 70 Complete https://irct.ir/trial/70152 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, permutation blocks method is used to assign people to the studied groups. Random allocation sequence of people will be done using Random Allocation Software and block size of four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of studied groups. Sealed envelopes are used to hide the assignment. Based on the order of entry of the research units, the envelopes will be opened in order and the assigned group will be revealed, Blinding description: This is a triple-blind study, in which participants, researchers and data analysts are among the blind groups of the study. In order to blind people, the drug and placebo are prepared in the form of capsules with completely similar packaging. There are codes on the packages that distinguish the drug from the placebo, and the researcher, research units and analysts are not aware of it. 3 primary dysmenorrhea. Intervention 1: Intervention group: 35 girls living in the dormitories of Ferdowsi University, who meet the inclusion criteria, were given oral capsules containing hydroalcoholic extract of coriander seeds with a dose of 500 mg for five days in two menstrual cycles. It is prepared and given by the pharmacist consultant professor, and during this time, the effect of the medicine on the intensity and duration of their menstrual pain is measured using designed questionnaires. Intervention 2: Control group: 35 girls living in the dormitories of Ferdowsi University who meet the inclusion criteria will be given an oral capsule containing a placebo (Avisel powder) for five days in two menstrual cycles. 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 further information
public Zohre Shahri
No. 11, Hafez apartment, Alley in front of Farzanegan High School, Nasr street, Ziba shahr
Zahedan Iran (Islamic Republic of) 9816743764 +98 54 3261 2156 shahriz981@mums.ac.ir Mashhad University of Medical Sciences scientific Zohre Shahri
No. 11, Hafez apartment, Alley in front of Farzanegan High School, Nasr street, Ziba shahr
Zahedan Iran (Islamic Republic of) 9816743764 +98 54 3261 2156 shahriz981@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Be single Be in the age range of 18-30 years Have regular menstrual cycles Have moderate to severe dysmenorrhea Do not have a history of pelvic and abdominal disease Do not have a history of chronic diseases Do not have a history of pain in the abdomen and back except during menstrual bleeding Do not have a history of confirmed mental illnesses Not having severe mental stress in the last 6 months Not allergic to coriander Informed consent to participate in the study 18 years 30 years Female Unwillingness to continue cooperation The occurrence of a severe stressful event during the study period Taking contraceptives Irregular use of medicine or placebo in the amount of two consecutive doses Getting married during the study period Performing professional sports activities Taking any type of supplement and multivitamin Presence of benign breast or uterine cysts They have had a history of prostate cancer, breast cancer and ovarian cancer in their first degree relatives Use of other herbs or drugs effective on dysmenorrhea N94.4 Primary dysmenorrhea Treatment - Drugs Placebo Intervention group: 35 girls living in the dormitories of Ferdowsi University, who meet the inclusion criteria, were given oral capsules containing hydroalcoholic extract of coriander seeds with a dose of 500 mg for five days in two menstrual cycles. It is prepared and given by the pharmacist consultant professor, and during this time, the effect of the medicine on the intensity and duration of their menstrual pain is measured using designed questionnaires. Control group: 35 girls living in the dormitories of Ferdowsi University who meet the inclusion criteria will be given an oral capsule containing a placebo (Avisel powder) for five days in two menstrual cycles. Intensity and duration of pain in early painful menstruation. Timepoint: Measuring the intensity and duration of painful menstruation at the end of menstrual bleeding during two consecutive cycles and simultaneously with the start of the drug or placebo. Method of measurement: Questionnaires made by the researcher. Visual Analogue Scale. The amount of menstrual bleeding - duration of menstrual bleeding - physical symptoms associated with menstruation. Timepoint: After the end of menstrual bleeding in two consecutive cycles and at the same time as giving medicine or placebo. Method of measurement: Questionnaires made by the researcher. Mashhad University of Medical Sciences Approved 2023-05-15 Ethics Committee of Mashhad University of Medical Sciences Unit 11, Hafez Apartment, Farzangan Alley, Nasr Street Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)