The effect of Ocimum Basilicum leaf extract on the symptoms of Premenstrual Syndrome in the female university students

Determining the effect of basil leaf extract on premenstrual syndrome symptoms in female students

the randomized clinical controled trial, triple-blind, on 128 patients, and SPSS 22 statistical software will be used for data analysis.

Location: Dormitories in Khorramabad-Lorestan In the experimental group, basil capsules and in the control group, placebo will be consumed once a night, at 9-10 p.m., one to two hours before bedtime and with a glass of water, from 7 days before the start of menstrual bleeding until the third day of menstruation for 2 consecutive cycles. 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.

Entry criteria: 18-35 years of age single having PMS symptoms based on PSST Iranian residing in the dormitory having regular menstrual cycles Exclusion criteria: 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 having a history of ovarian cyst or gynecological surgeries sensitivity to basil extract not taking basil capsules for two consecutive days being on a special diet

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 the placebo capsule during this time and under the same conditions.

Symptoms of premenstrual syndrome

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.

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.