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IRCT20240510061726N1 IRCT 2024-07-29 Khoy University of medical science The effect of oral tablet of Black cohosh on the menstrual symptoms and dysmenorrhea The effect of oral tablet of Black cohosh on the menstrual symptoms and dysmenorrhea among female students: a randomized controlled trial 2024-05-14 anticipated 50 Complete https://irct.ir/trial/76769 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: The list of students is taken and they are selected by a simple random method and they are contacted. Qualified people are randomly allocated into two black cohosh groups using a random block size of four and six blocks and with a ratio of 1:1. and a placebo will be placed. The pills are placed in opaque bottles numbered consecutively and will be delivered to the participants in the order they enter the study. The researcher and the participants will not know the type of drug. It should be noted that the placebo will be completely similar to the original drug in terms of shape, color, and other appearance characteristics and will be manufactured by the pharmaceutical company, Blinding description: In this study, there will be three blinded sides.Participants, the researcher and the analyst will be blind. The type of original drug and placebo will be the same in terms of shape, color, smell and size, and none of the participants will be aware of the type of drug used. In the same way, the researcher and the analyst will not know the type of drug and the list of drugs will be at the disposal of the person not involved in the study. 3 Dysmenorrhea and premenstrual symptoms. Intervention 1: Intervention group: For the intervention group, black cohosh herbal medicine with the medicinal name of Simi Fogel, which Gol Daru Company manufactures, will be used. This medicine is in the form of coated tablets that contain 6.5 mg of dry extract of black cohosh root. This medicine will be taken 7 tablets monthly (5 tablets on the day before menstruation and 2 tablets during menstruation) by female students for 2 months. The pharmacist approves this treatment protocol of the team, and in previous similar articles, the same dose has been used on menopause. Intervention 2: Control group: For the control group, the placebo drug will be made exactly the same as the original drug by Isfahan Gol Daru Company. Yes - There is a plan to make this available What will be shared: Parts of the data, such as information related to the main outcome, will be report after de-identifying people When: The access period starts 6 months after the results are published To whom: researchers and students Conditions: Study data can only be used by mentioning the source Where to obtain: The scientific response of the study to the treatment of Nasrin Zamiri Miandoab with the email address nasriinzamiri@gmail.com How to obtain: The applicant can receive the data by sending an email to the corresponding author Comments:
public nasrin zamiri-miandoab
khoy, Valiasr blvd,
khoy Iran (Islamic Republic of) 5816753464 +98 44 3625 5777 nasriinzamiri@gmail.com khoy university of medical science scientific Nasrin zamiri-miandoab
Khoy, Valiasr Blvd
Khoy Iran (Islamic Republic of) 5816753464 0098443625777 nasriinzamiri@gmail.com Khoy University of medical science Iran (Islamic Republic of) Regular menstruation 21-35 days Age 18-30 years insensitivity to black cohosh and other herbal medicines containing phytoestrogens (soybeans, flax seeds, lentils, mung beans, etc.) According to the person's statement Not taking any medication to treat dysmenorrhea at the same time as research Having primary dysmenorrhea (with VAS score ≥ 4) Not having liver problems according to the person's own statement not married Complaining of menstrual symptoms (cramps, headache, abdominal pain, mood disorders, etc.) 18 years 30 years Female First semester students Use of other herbal medicines and painkillers. The occurrence of a stressful event (such as the death of a first-degree family member and the diagnosis of an incurable or incurable disease for a family member during the last three months) Abuse of tobacco and alcohol Having any acute or chronic disease (such as epilepsy, cardiovascular, digestive, liver, blood, endocrine) History of any female disease such as abnormal pelvic anatomy, lack of ovulation, or abnormal pattern of uterine bleeding Surgery in the last three months Insensitivity to black cohosh and other herbal medicines containing phytoestrogens (soybeans, flax seeds, lentils, mung beans, etc.)according to the person's statement. Taking antidepressants (such as serotonin and noradrenaline reuptake inhibitors, antihistamines, barbiturates, narcotics, diazepam, amphetamines, and cocaine) N94.4 Primary dysmenorrhea Treatment - Drugs Treatment - Drugs Intervention group: For the intervention group, black cohosh herbal medicine with the medicinal name of Simi Fogel, which Gol Daru Company manufactures, will be used. This medicine is in the form of coated tablets that contain 6.5 mg of dry extract of black cohosh root. This medicine will be taken 7 tablets monthly (5 tablets on the day before menstruation and 2 tablets during menstruation) by female students for 2 months. The pharmacist approves this treatment protocol of the team, and in previous similar articles, the same dose has been used on menopause Control group: For the control group, the placebo drug will be made exactly the same as the original drug by Isfahan Gol Daru Company Menstrual symptoms. Timepoint: The beginning of the study and the end of the study. Method of measurement: Menstrual symptoms intensity scale SSS. Primary dysmenorrhea. Timepoint: The beginning of the study and the end of the study. Method of measurement: visual pain scale (VAS). Khoy University of medical science Approved 2024-05-01 Ethics committee of khoy University of Medical Sciences khoy, Valiasr Blvd, khoy University of Medical Sciences خوی West Azarbaijan Iran (Islamic Republic of)