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IRCT20220720055514N1 IRCT 2022-08-30 Mashhad University of Medical Sciences Comparison of the effect of Vitagnus capsules, Soy and the combination of Vitagnus and Soy in students with premenstrual syndrome Comparison of the effect of Vitagnus capsules, Soy and the combination of Vitagnus and Soy in students with premenstrual syndrome 2022-09-06 anticipated 108 Complete https://irct.ir/trial/64979 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to guarantee an equal number of study subjects in two groups, random permutation block method is determined using the website www.sealedenvelope.com. In this way, a number of 4-member blocks are created by accident through the above site. For example, the blocks can be as follows: [ABCABC], [BACBAC], [CACBAB], , Blinding description: This study is double-blind so that the researcher and the participants will not know which group each person will be placed in. 2 Premenstrual syndrome. Intervention 1: The first intervention group: 500 mg Vitagnus and soy combined capsule, containing 20 mg dry extract of Vitex agnus-castus and 250 mg Soy powder, once a day after breakfast for 2 consecutive menstrual cycles. Intervention 2: The second intervention group: Vitagnus 500 mg capsule, containing 40 mg dry extract of Vitex agnus-castus, once a day after breakfast for 2 consecutive menstrual cycles. Intervention 3: The third intervention group: 500 mg Soy capsule, containing 500 mg soy powder, once a day after breakfast for 2 consecutive menstrual cycles. Yes - There is a plan to make this available What will be shared: Publication of research results in the form of scientific article printining When: data will become available after publication of the To whom: The general public and all researchers Conditions: For use in the treatment of premenstrual syndrome and scientific use based on the article Where to obtain: En Dr. Maryam Moradi, Assistant Professor, Mashhad School of Midwifery Nursing, e-mail: moradim@mums.ac.ir How to obtain: Request to access data through email and request will be assessed by the research team. Comments:
public Roya Partovigolshan
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Partovigolshan69@gmail.com Mashhad University of Medical Sciences scientific Dr Maryam Moradi
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
Mashhad Iran (Islamic Republic of) 9137913199 0098 51 38591511-3 moradim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Be a student living in the dormitory of Mashhad University of Medical Sciences Have written and informed consent to participate in the study Be of Iranian and Muslim nationality Be single Be 16-45 years old Have regular menstruation with menstrual intervals of 21-38 days and a bleeding period of less than 7 days Have a BMI less than 30 kg/m2 Have 5 or more than 5 symptoms out of 11 symptoms of the premenstrual syndrome temporary diagnosis form and at least one of the first 4 symptoms of the questionnaire Do not suffer from physical or mental illness Do not suffer from severe Depression, Stress and Anxiety according to DASS 21 form Not taking any special medicine She has not taken effective drugs (chemical or herbal) on premenstrual syndrome in the last three months Has not experienced an unfortunate accident in the last 6 months Not a professional athlete Do not follow a special diet or vegetarian diet Not allergic to Vitagnus and Soy products No history of breast cancer in first degree relatives Do not consume Alcohol, Cigarettes or any drugs 16 years 45 years Female Get married while studying Complications or allergies to Vitagnus medicine, Soy, or the combination of Vitagnus and Soy occur Experienced any unfortunate incident while studying Suffer physical and mental illness while studying Do not use any type of treatment to relieve symptoms of PMS during the study period Do not complete the daily symptom registration questionnaire or complete the form incompletely Do not use the medicine according to the instructions and opinion of the pharmacologist Do not want to continue taking medicine and cooperate in the plan N94.3 Premenstrual tension syndrome Prevention Prevention Prevention The first intervention group: 500 mg Vitagnus and soy combined capsule, containing 20 mg dry extract of Vitex agnus-castus and 250 mg Soy powder, once a day after breakfast for 2 consecutive menstrual cycles. The second intervention group: Vitagnus 500 mg capsule, containing 40 mg dry extract of Vitex agnus-castus, once a day after breakfast for 2 consecutive menstrual cycles. The third intervention group: 500 mg Soy capsule, containing 500 mg soy powder, once a day after breakfast for 2 consecutive menstrual cycles. The mean score of severity of physical, mental and total premenstrual syndrome by the premenstrual events calendar form (COPE). Timepoint: The average symptom severity score at the end of the first and second cycles after the intervention compared to before the intervention in the three groups receiving Vitagnus capsules, Soy and the combination of Vitagnus and Soy. Method of measurement: Premenstrual Events Calendar Questionnaire (COPE). Dysmenorrhea or menstrual pain. Timepoint: The average score of menstrual pain intensity at the end of the first and second cycles after the intervention compared to before the intervention in three groups receiving Vitagnus capsules, Soy and the combination of Vitagnus and Soy. Method of measurement: Visual Pain Scale Questionnaire (VAS). Mashhad University of Medical Sciences Approved 2022-07-19 Ethics Committee of Mashhad University of Medical Sciences Qureshi Building., University Street., Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)