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IRCT20180524039815N1 IRCT 2018-05-31 Deputy of Research of Tabriz University of Medical Sciences Effect of Citrus Aurantium extract on painful menstruation Comparison of the effect of Citrus Aurantium extract with Mefenamic Acid on the intensity of Primary Dismenorrhea 2018-06-22 anticipated 105 Complete https://irct.ir/trial/31447 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially the qualified participants will be asked to fill the individual, demoghraphic,menstrual and visual pain scale questionnaires one month before beginning of the medications(Citrus Aurantium extract,Mefenamic Acid,Placebo) and in the first three days of the cycle. Randomization will be based on Fixed size block randomization. In selection of blocks random numbers table will be used, Blinding description: 250 mg capsules containing Citrus Aurantium extract or Mefenamic Acid or Placebo(Starch) which are similar in shape, color, size and aroma, are made at Tabriz Faculty of Pharmacy and Tabriz Medical Science Research and Development Center. They are placed in the envelopes A, B and C by the pharmacist. Each code indicates that there is one type of capsule inside the envelope. The researcher will randomly distribute the envelopes among eligible participants in the study. ŮŽApart from the pharmacist, investigator or participants, will be unaware of the envelopes content. The researcher will not know which of the participants will use the envelope A or the envelope B or the envelope C. The type of the medicines inside the envelopes will not be obvious to the researcher and participants. 2-3 Primary Dysmenorrhea. Intervention 1: Intervention group: Citrus Aurantium extract 250 mg capsule every 8 hours during the first three days of the cycle. Intervention 2: Intervention group: Mefenamic Acid 250 mg capsule every 8 hours during the first three days of the cycle. Intervention 3: Intervention group: Placebo 250 mg capsule(containing starch) every 8 hours during the first three days of the 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 Depending on the conditions and privacy compliance will be decided
public Dr.Parvin Bastani
Rah Ahan Ave. Taleghani Hospital
Tabriz Iran (Islamic Republic of) 5158493390 +98 41 3331 0477 Bastani.parvin@yahoo.com Tabriz University of Medical Sciences scientific Farkhondeh Aboualsoltani
Traditional Medicine Faculty,Tabriz University of Medical Sciences,Gholgasht St, Azadi Ave
Tabriz Iran (Islamic Republic of) 5158493390 +98 41 3331 0477 far_absl@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Being single-Age from 15 to 20 Having Primary Dysmenorrhea with moderate to severe intensity accourding to Mcgill pain scale atleast for the last cycle Regular distance between menstrual cycles No previous abdominal or pelvic surgery No symptomes like irritation, burning or abnormal vaginal secretions No past history of pelvic inflammatory disease,Endometriosis,Myoma and tumor No stressful situations like death of first degree relatives, seperation of parents,... in the last 6 months. 15 years 20 years Female Unwillingness to take medication for different reasons like severe side effects or discontent Using any medicine or herbal product Being allergic to Citrus Aurantium flower. N94.4 Primary dysmenorrhea Treatment - Drugs Treatment - Drugs Placebo Intervention group: Citrus Aurantium extract 250 mg capsule every 8 hours during the first three days of the cycle Intervention group: Mefenamic Acid 250 mg capsule every 8 hours during the first three days of the cycle Intervention group: Placebo 250 mg capsule(containing starch) every 8 hours during the first three days of the cycle Intensity of Dysmenorrhea. Timepoint: Monthly. Method of measurement: Visual Analogue Scale(VAS) - Mcgill pain scale. Days of bleeding. Timepoint: Daily. Method of measurement: Questionnaire. Distance between two cycles. Timepoint: Day. Method of measurement: Questionnaire. Physical activity. Timepoint: Monthly. Method of measurement: Questionnaire. Complications of interventions. Timepoint: During intervention. Method of measurement: Questionnaire-Report-Observation. Deputy of Research of Tabriz University of Medical Sciences Approved 2018-04-21 Ethics committee of Tabriz University of Medical Sciences Daneshgah Ave, Pharmacy Faculty Tabriz East Azarbaijan Iran (Islamic Republic of)