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IRCT20120718010324N71 IRCT 2022-09-18 Tabriz University of Medical Sciences The effect of curcumin on the premenstrual syndrome and dysmenorrhea The effect of oral capsule of curcumin on the premenstrual syndrome and dysmenorrhea among students in Tabriz, Iran: a randomized controlled trial 2022-09-20 anticipated 62 Complete https://irct.ir/trial/65582 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The present study is a triple-blind randomized clinical trial. Students will be randomly assigned to curcumin and placebo groups with the block sizes of four and six and allocation ratio of 1:1. To conceal the allocation, same shape, same size, opaque, sealed and consecutively numbered medicine bottles will be used. Inside each medicine bottle, 20 oral capsules of curcumin or placebo will be placed to be taken once a day for a period of 10 days in each menstrual cycle (from 7 days before the start of menstruation to 3 days after the start of menstruation), Blinding description: The current research is a triple-blind randomized clinical trial in which the participant, clinical caregiver, researcher, outcome assessor, and data analyst were blinded. 3 Condition 1: Premenstrual syndrome. Condition 2: Dysmenorrhea. Intervention 1: Intervention group: The participants (31 people) will receive curcumin oral supplement in the form of gelatin capsules with a dosage of 500 mg with the trade name (Curcuma longa extract complexed with phosphatidyl choline; NOW®). Curcumin supplement contains a combination of curcumin and phosphatidylcholine. The time to take the supplement is once a day and after a meal. The duration of taking the supplement will be 10 days in each menstrual cycle (from 7 days before the start of menstruation to 3 days after the start of menstruation) for two menstrual cycles. Intervention 2: Control group: The participants (31 people) will receive the placebo in the form of capsules with a dose of 500 mg. The placebo ingredients will consist of corn starch, which will be used at the same time as the curcumin supplement once a day and after a meal. Also, the duration of taking placebo will be 10 days in each menstrual cycle (from 7 days before the start of menstruation to 3 days after the start of menstruation) for two 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 I have not decided.
public Sepideh Mashayekh Amiri
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
Tabriz Iran (Islamic Republic of) 977-5138947 +98 41 3479 6770 Sepidehmashayekh@yahoo.com Tabriz University of Medical Sciences scientific Dr. Mojgan Mirghafourvand
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
Tabriz Iran (Islamic Republic of) کدپستی: 977-5138947 +98 41 3479 6770 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Regular menstruation (21-35 days) Having primary dysmenorrhea and premenstrual syndrome (with VAS score ≥ 4 and PSST score ≥ 20) Age 18-25 years Not allergic to turmeric Not taking any medicine to treat the symptoms of premenstrual syndrome at the same time as the research 18 years 25 years Female Abuse of tobacco and alcohol Use of other herbal medicines The occurrence of a stressful event (such as the death of a first-degree family member and the diagnosis of an incurable disease for a family member during the last three months) Having any acute or chronic disease (such as epilepsy, cardiovascular, digestive, liver, blood, endocrine) History of any gynecological disease, such as abnormal pelvic anatomy, lack of ovulation, or abnormal pattern of uterine bleeding. Surgery in the last three months Taking antidepressants (such as serotonin and noradrenaline reuptake inhibitors, antihistamines, barbiturates, narcotics, diazepam, amphetamines, and cocaine) Taking anticoagulants such as heparin, aspirin, clopidogrel, dipyridamole, warfarin, enoxaparin and ticlopidine. N94.3 N94.4 Premenstrual tension syndrome Primary dysmenorrhea Treatment - Drugs Placebo Intervention group: The participants (31 people) will receive curcumin oral supplement in the form of gelatin capsules with a dosage of 500 mg with the trade name (Curcuma longa extract complexed with phosphatidyl choline; NOW®). Curcumin supplement contains a combination of curcumin and phosphatidylcholine. The time to take the supplement is once a day and after a meal. The duration of taking the supplement will be 10 days in each menstrual cycle (from 7 days before the start of menstruation to 3 days after the start of menstruation) for two menstrual cycles. Control group: The participants (31 people) will receive the placebo in the form of capsules with a dose of 500 mg. The placebo ingredients will consist of corn starch, which will be used at the same time as the curcumin supplement once a day and after a meal. Also, the duration of taking placebo will be 10 days in each menstrual cycle (from 7 days before the start of menstruation to 3 days after the start of menstruation) for two menstrual cycles. Premenstrual syndrome. Timepoint: The first assessment before entering the study and the second assessment in one month after the intervention and the third assessment in 2 months after the intervention. Method of measurement: Premenstrual symptoms screening tool (PSST). Dysmenorrhea. Timepoint: The first assessment before entering the study and the second assessment in one month after the intervention and the third assessment in 2 months after the intervention. Method of measurement: Visual analogue scale (VAS). Tabriz University of Medical Sciences Approved 2022-08-29 Ethics committee of Tabriz University of Medical Sciences Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)