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IRCT20160709028844N1 IRCT 2023-04-26 Shahre-kord University of Medical Sciences oral calcium and magnesium on the reduction of pms Comparative study of the effect of oral calcium and magnesium on the reduction of PMS 2018-11-21 anticipated 195 Complete https://irct.ir/trial/69075 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: There is no case, Randomization description: The study was conducted in a double-blind and randomization method using stratified random allocation, so that according to the severity of PMS, the patients were divided into three categories: very severe, moderate to severe, and mild, and in each category, they were randomly assigned to three groups A and B. and C were divided. A total of 204 female students living in the dormitory of Shahrekord University of Medical Sciences with PMS were divided in terms of physical symptoms and psychological symptoms, and as a result, 66 people were in the mild category, 84 people were in the moderate category, and 54 people were in the severe category. The random sequence was obtained through the online randomization program (program address: https://www.sealedenvelope.com/simple-randomiser/v1/lists) And based on the random list, each patient was assigned to one of the groups A, B, and C, respectively. In terms of the severity of premenstrual syndrome, in each group of 68 people, there were an equal number of 22 mild, 28 moderate and 18 severe patients. After filling the consent form, the drugs were prepared by a pharmacologist from Dr. Abedi Pharmaceutical Company and divided into three packages of the same color. And one shape was named with letters A, B and C. Group A contained 1000 mg of calcium, group B contained 300 mg of magnesium, and group C contained selenium as a placebo. The patients and the researcher did not know about the contents of the package, Blinding description: he study was double-blind and the drugs were given to the study subjects in packages of the same shape, A, B, and C, and the patients and the researcher did not know about the contents of the package. 3 Premenstrual syndrome. Intervention 1: Group A consumed 1000 mg of calcium per day for the study period of 3 cycles from the 15th day of the menstrual cycle or immediately after ovulation to the start of menstrual bleeding, and at the end of the cycle and with the beginning of bleeding, they completed the PSST questionnaire. Intervention 2: Group B consumed 300 mg of magnesium daily for the study period of 3 cycles from the 15th day of the menstrual cycle or immediately after ovulation to the onset of menstrual bleeding, and at the end of the cycle and with the onset of bleeding, they completed the PSST questionnaire. Intervention 3: Group C used selenium tablets for placebo for 3 study cycles from the 15th day of the menstrual cycle or immediately after ovulation to the beginning of menstrual bleeding, and at the end of the cycle and with the onset of bleeding, they completed the PSST questionnaire. 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 Uncertainty of results
public Sheida Shabanian
Parastar Ave
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 shabanian@skums.ac.ir Shahre-kord University of Medical Sciences scientific Sheida Shabanian
Parastar Ave
Sharekord Iran (Islamic Republic of) 8816746633 +98 38 3222 0016 shabanian@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Female students of Shahrekord University of Medical Sciences with definite diagnosis of premenstrual syndrome Not using other treatment methods Willingness to participate in the study Not suffering from known physical and mental diseases single Calendar age 18 to 27 years Regular menstrual cycle of 21 to 35 days Menstruation duration 3-7 days during the last six months In terms of the severity of PMS symptoms, they were matched according to the DSM-V score 18 years 27 years Female Reluctance to participate in the study Use of other treatment methods N94.3 Premenstrual tension syndrome Treatment - Drugs Treatment - Drugs Placebo Group A consumed 1000 mg of calcium per day for the study period of 3 cycles from the 15th day of the menstrual cycle or immediately after ovulation to the start of menstrual bleeding, and at the end of the cycle and with the beginning of bleeding, they completed the PSST questionnaire. Group B consumed 300 mg of magnesium daily for the study period of 3 cycles from the 15th day of the menstrual cycle or immediately after ovulation to the onset of menstrual bleeding, and at the end of the cycle and with the onset of bleeding, they completed the PSST questionnaire Group C used selenium tablets for placebo for 3 study cycles from the 15th day of the menstrual cycle or immediately after ovulation to the beginning of menstrual bleeding, and at the end of the cycle and with the onset of bleeding, they completed the PSST questionnaire Premenstrual syndrome. Timepoint: The beginning of the study and 1, 2 and 3 months after the study. Method of measurement: PMS diagnostic criteria based on DSM-V. Physical and mental symptoms. Timepoint: 0 start of study and 1 month, 2 months and 3 months later. Method of measurement: DSM-V. Shahre-kord University of Medical Sciences Approved 2018-05-23 Ethics committee of Shahrekord University of Medical Sciences No. 4, 36 Yaser Ave Shahrekord Town Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)