]>
IRCT20191112045424N1 IRCT 2020-01-23 Birjand University of Medical Sciences The effect of curcuminoids on menstrual disorders طرح کورکومین Effect of Supplementation with Curcuminoids on the Menstrual problems, Severity of Premenstrual Syndrome and Dysmenorrhea; A randomized triple-blind clinical trial 2020-01-25 anticipated 148 Complete https://irct.ir/trial/43634 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Other design features: None, Randomization description: After careful examination of those with dysmenorrhea and PMS, these individuals are identified and assigned a number ranging from 1 to 148. Then, from numbers 1 through 148, 74 are selected using the random number table, and individuals are assigned to drug A. Then the remaining 74 people receive B medicine, Blinding description: This is a randomized triple-blind controlled clinical trial Initially, the pharmaceutical company determined drug and placebo with two types of A and B codes, and the researcher, patients, and statistical analysts did not know whether A or B was a drug or a placebo. Then, patients were randomly assigned to either group A or group B by random selection. Therefore, the researcher, patients and statistical analyst are kept blind until the end of the study. 3 Having both premenstrual syndrome and dysmenorrhea. Intervention 1: Intervention group: (n=74) reception of curcuminoids (500 mg/day), for seven days before the start of bleeding until three days after that for three menstrual cycles. Intervention 2: Control group: reception of placebo that resembles curcumin capsules in shape, color and size but contains 500 mg of corn starch, for seven days before the start of bleeding until three days after that for three 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 No more information
public Afsane Bahrami
Birjand University of Medical Sciences, Ghaffari Ave
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3239 1569 Afsbahrami91@yahoo.com Birjand University of Medical Sciences scientific Afsane Bahrami
Birjand University of Medical Sciences, Ghaffari Ave.
Birjand Iran (Islamic Republic of) 9717853577 +98 915 521 9274 Afsbahrami91@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Simultaneous diagnosis of premenstrual syndrome and primary dysmenorrhea Being single BMI between 19 and 25 Ages 18-25 years Informed consent to participate in the project 18 years 25 years Female Acute or chronic illness during study The occurrence of a traumatic event such as the death of a relative during the studyMarriage Marriage during study Treatment - Drugs Treatment - Drugs Intervention group: (n=74) reception of curcuminoids (500 mg/day), for seven days before the start of bleeding until three days after that for three menstrual cycles Control group: reception of placebo that resembles curcumin capsules in shape, color and size but contains 500 mg of corn starch, for seven days before the start of bleeding until three days after that for three menstrual cycles People with premenstrual syndrome and dysmenorrhea. Timepoint: Before intervention, 3 months later. Method of measurement: Premenstrual Syndrome severity questionnaire, digital barometer, digital scale. Birjand University of Medical Sciences Approved 2019-07-15 National Ethics Committee In Biomedical Research Birjand, Ghaffari Street Birjand South Khorasan Iran (Islamic Republic of)