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IRCT20250308064992N1 IRCT 2025-04-08 Khoram-Abad University of Medical Sciences The effect of Ocimum Basilicum on Premenstrual Syndrome The effect of Ocimum Basilicum leaf extract on the symptoms of Premenstrual Syndrome in the female university students 2025-04-21 anticipated 128 Complete https://irct.ir/trial/82378 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method is accessible and based on the study entry criteria. In this way, after obtaining written consent from the samples, people are assigned to intervention and control groups using block random allocation method and blocks of 4. By using this method, it can be ensured that an equal number of participants enter the intervention and control groups in consecutive time intervals. Entry of people into each of the groups is done according to the number of selected blocks and the arrangement inside the block. For blocks of 4, six modes are considered as follows, and the said blocks will be used approximately 6 times so that the final sample size is allocated to two treatment and intervention groups: 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC All assessments and interventions will be conducted by the primary investigator, who is unaware of the group randomization, Blinding description: The drug (basil) and the placebo are placed in the same packaging and envelopes coded by a trained midwife with 2 codes (code A for basil capsule and code B for placebo), which are similar in shape and size. Neither the patient nor the person evaluating the patient will know what medication has been received. Also, the data analyst will be blind to the grouping. 3 Premenstrual syndrome. Intervention 1: The intervention group will receive a 250 mg basil capsule daily for two cycles, 7 days before the onset of menstruation until 3 days after menstrual bleeding. Intervention 2: The Control group will receive a 250 mg placebo capsule daily for two cycles, 7 days before the onset of menstruation until 3 days after menstrual bleeding. 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 There is no further information.
public Soheila Pirdadeh Beiranvand
Department of midwifery, faculty of nursing and midwifery, pardis medical campus, kamalvand, Khorramabad,Lorestan,Iran
Khorramabad Iran (Islamic Republic of) 381351698 +98 66 1322 9095 kimia_n72@gmail.com Khoram-Abad University of Medical Sciences scientific Soheila Pirdadeh Beiranvand
Department of midwifery, faculty of nursing and midwifery, pardis medical campus, kamalvand, Khorramabad, Lorestan, Iran
Khorramabad Iran (Islamic Republic of) 381351698 +98 66 1322 9095 kimia_n72@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) 18-35 years of age single having PMS symptoms based on PSST questionnaire Iranian residing in the dormitory having regular menstrual cycles 18 years 35 years Female having a record of regular physical exercise consuming alcohol, narcotics, or smoking Occurrence of menstrual disorders having a history of underlying conditions leading to PMS taking any type of drug regularly using therapeutic measures to prevent premenstrual problems having undergone an adverse experience or a disaster being stressed, anxious or depressed as indicated by DASS21 test having a history of ovarian cyst or gynecological surgeries sensitivity to basil extract during the study not taking basil extract capsules for two consecutive days being on a special diet N94.3 Premenstrual tension syndrome Treatment - Drugs Placebo The intervention group will receive a 250 mg basil capsule daily for two cycles, 7 days before the onset of menstruation until 3 days after menstrual bleeding. The Control group will receive a 250 mg placebo capsule daily for two cycles, 7 days before the onset of menstruation until 3 days after menstrual bleeding. Severity of premenstrual syndrome. Timepoint: Symptom severity will be measured before the study, one and two cycles after the study. Method of measurement: The Premenstrual Symptoms Screening Tool. Khoram-Abad University of Medical Sciences Approved 2025-03-08 Ethics committee of Lorestan University of Medical Sciences Headquarters of Lorestan University of Medical Sciences, Anoushirvan Rezaei Square, Moalem St. Khorramabad Lorestan Iran (Islamic Republic of)