]>
IRCT20200904048614N1 IRCT 2020-11-19 Shahid Beheshti University of Medical Sciences Effects of Capsule Capsella bursa pastoris on Primary Dysmenorrhea Severity in Women Referred to Medical Center Affiliated to Kermanshah University of Medical Sciences in 2020 Effects of Capsule Capsella bursa pastoris on Primary Dysmenorrhea Severity in Women Referred to Medical Center Affiliated to Kermanshah University of Medical Sciences in 2020 2020-11-23 anticipated 80 Complete https://irct.ir/trial/52067 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The simple random sampling and individual entities in random unit will be used. In order to randomize and allocate individuals to groups, random number function will be used. Randomization is as follow using excel software: first, groups will be entered in one column as A,B together; as the number of samples in each group has been defined as 40 (including sample drop), thus, B, A, 40 should be entered in order and beneath. In the other column , using the command RAND , the random numbers are generated . In the next step, using the command sort, the generated random numbers will be organized ranging from lowest numbers to highest ones or vice versa, this will result a change in groups order as A, B. Using the new order, individuals will be allocated to different groups, Blinding description: The study is triple blind. This means that the researcher, participants, and statistic consultant will have no information about the drugs used by each group or each A or B packs filled with which type of drugs . 3 Primary Dysmenorrhea. Intervention 1: Intervention group: the participants of the intervention group will take 400mg capsella bursa-pastoris capsules three times a day every 8 hours from the first day of menstrual cycle (second and third) to the third day of menstrual cycle (totally 3 days). Intervention 2: Control group:the participants of the control group will take 250mg Mefenamic Acid capsules three times a day every 8 hours from the first day of menstrual cycle (second and third) to the third day of menstrual cycle (totally 3 days). Yes - There is a plan to make this available What will be shared: - When: - To whom: - Conditions: - Where to obtain: - How to obtain: - Comments:
public Saeedeh Ahmadipoor
Postal code:6719997788,North Fifth Door,Ordibehesht 3rd Alley,Ostad Shahriyar St.,Justice Town,Kermanshah
Kermanshah Iran (Islamic Republic of) 6719997788 +98 83 3826 6937 saeedehahmadipur@gmail.com Shahid Beheshti University of Medical Sciences scientific Fatemeh Nahidi
School of Nursing and Midwifery,In front of Shahid Rajaei Heart Hospital,Niayesh Intersection,Valiasr Street,Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 nahidifateme@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Those with primary dysmenorrhea that their pain rated from moderate to severe according to Mac Gill pain scale. They are between 18-30 years old. They have experienced menstrual pain during the first three days of the menstruation for three consecutive periods in the last 6 months. They have 3-7 days of menstrual bleeding. They do not experience bleeding between two menstrual cycles. They have 21-35-day and regular menstrual cycles. They have no chronic disease (diabetes, hypertension, heart diseases, infectious disease, liver and kidney diseases, epilepsy, and pelvis diseases (fibromas, endometriosis) according to their statements. They have no abnormal vaginal discharge. They do not take special medication and supplements. 18 years 30 years Female Those with primary dysmenorrhea that their pain rated as mild according to Mac Gill pain scale. Those with secondary dysmenorrhea. Those with underlying diseases. N94.4 Primary dysmenorrhea Treatment - Drugs Treatment - Drugs Intervention group: the participants of the intervention group will take 400mg capsella bursa-pastoris capsules three times a day every 8 hours from the first day of menstrual cycle (second and third) to the third day of menstrual cycle (totally 3 days). Control group:the participants of the control group will take 250mg Mefenamic Acid capsules three times a day every 8 hours from the first day of menstrual cycle (second and third) to the third day of menstrual cycle (totally 3 days). Percentage of individual with primary dysmenorrhea whose pain rate is upper than 4 according to Mac Gill pain scale. Timepoint: Measuring the intensity of dysmenorrhea during the first three days of the menstrual cycle ( first month ) without intervention, during the first three days of the menstrual cycle ( second month ) with intervention, during the first three days of the menstrual cycle ( third month ) with intervention. Method of measurement: Visual Analogue Scale. Shahid Beheshti University of Medical Sciences Approved 2020-06-15 Ethics committee of Shahid Beheshti University of Medical Sciences Postal code:6719997788,North Fifth Door,East 3rd Alley,Ostad Shahriyar St.,Justice Town,Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)