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IRCT20220512054829N2 IRCT 2022-10-28 Kashan University of Medical Sciences effect of Fennelin on primary dysmenorrhoea ندارد comparsion of the effect of Fennelin and diclofenac on primary dysmenorrhea 2022-07-30 anticipated 100 Complete https://irct.ir/trial/64836 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Randomization is done with the block method (Permuted block randomization) so that first All blocks of four that include two codes A and B (6 blocks) are prepared and numbers from 1 to 6 are assigned to each of them. Then, using the table of random numbers, each number from 1 to 6 that is selected, the block corresponding to each code will be written(25 blocks). Based on this, a sequence of codes A and B is prepared for 100 codes (proportionate to the number of samples). Then, each of the letters A and B is randomly assigned to one of the fennelin and diclofenac groups. The same code is recorded on each drug and will remain with the formulation department until the end of the study. At the end of the study, the code of the drugs in the form of A and B will be provided to the statistical analyst for analysis, Blinding description: The drugs in both groups are packaged In vials of one shape and one size in the formulation section of Barij Essential Oil Pharmaceutical Company, then coded based on codes previously prepared using a random number table. 2 Primary dysmenorrhea. Intervention 1: Intervention group 1: People take one 30 mg pearl fennelin three times a day after meals with the onset of dysmenorrhea. Each milliliter of this substance contains less than 11.4 mg of anthole as an active ingredient. Phenylin has similar packaging as Diclofenac with the name "Stapin" is designed by Barij Essential Oil Pharmaceutical Company .The drug is used for two menstrual periods and for four days in each period. Intervention 2: Intervention group 2: People take one 100 mg diclofenac tablet three times a day with the onset of dysmenorrhea after meals. Diclofenac has the same packaging as fennelin with the name "Stopain" designed by Hakim Pharmaceutical Company .The drug is used for two menstrual periods and for four days in each period. 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 Its release schedule is not known. There is no more information
public Hossein Akbari
ُShahid Beheshti Hospital,Qutb Rawandi Blvd،Kashan
Kashan Iran (Islamic Republic of) 8715985131 +98 31 5558 9057 akbari1350_h@yahoo.com Kashan University of Medical Sciences scientific Hossein Akbari
Shahid Beheshti Hospital، Parastar Blvd, ،Qutb Rawandi Blvd
Kashan Iran (Islamic Republic of) 8715985131 +98 31 5558 6057 akbari1350_h@yahoo.cim Kashan University of Medical Sciences Iran (Islamic Republic of) Regular menstruation Moderate and severe dysmenorrhea Age between 15-30 15 years 30 years Female People with underlying diseases User of other drugs genital diseases N94.4 Primary dysmenorrhea Treatment - Drugs Treatment - Drugs Intervention group 1: People take one 30 mg pearl fennelin three times a day after meals with the onset of dysmenorrhea. Each milliliter of this substance contains less than 11.4 mg of anthole as an active ingredient. Phenylin has similar packaging as Diclofenac with the name "Stapin" is designed by Barij Essential Oil Pharmaceutical Company .The drug is used for two menstrual periods and for four days in each period Intervention group 2: People take one 100 mg diclofenac tablet three times a day with the onset of dysmenorrhea after meals. Diclofenac has the same packaging as fennelin with the name "Stopain" designed by Hakim Pharmaceutical Company .The drug is used for two menstrual periods and for four days in each period. Moderate to severe dysmenorrhoea according to Andresh and Milsom questionnaire. Timepoint: Examination of the severity of dysmenorrhea at the beginning of the study before the intervention and on the 1st, 2nd, 3rd and 4th day of menstruation after the intervention. Method of measurement: Andres and Milsom questionnaire. Nausea with dysmenorrhea. Timepoint: At the beginning of drug use and days 1, 2, 3, and 4 of dysmenorrhea in two consecutive menstrual periods. Method of measurement: Andrash and Milsom questionnaire. Vomiting with dysmenorrhea. Timepoint: At the beginning of drug use and days 1, 2, 3, and 4 of dysmenorrhea in two consecutive menstrual periods. Method of measurement: Andrash and Milsom questionnaire. Back pain with dysmenorrhea. Timepoint: At the beginning of drug use and days 1, 2, 3, and 4 of dysmenorrhea in two consecutive menstrual periods. Method of measurement: Andrash and Milsom questionnaire. Kashan University of Medical Sciences Approved 2022-07-03 Ethics Committee of Faculty of Medicine & Faculty of Dentistry- Kashan University of Medical Science Kashan University of Medical Sciences ،Pezeshk street ،Ghotb ravandi BLVD Kashan Isfehan Iran (Islamic Republic of)