The effect of Ocimum Basilicum leaf extract on the sleep quality in the female university students

Determining the effect of basil leaf extract on sleep quality in female students

the randomized clinical controled trial, triple-blind, on 94 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, for a month. 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.

Inclusion criteria: 1. Age between 18 and 35 years 2. Single 3. Iranian 4. Dormitory resident 5. Having sleep quality disorder according to the Pittsburgh questionnaire 6. Body mass index between 18.5 and 35 Exclusion criteria: 1. Alcohol and tobacco consumption 2. Consumption of more than 4 cups of coffee during the day 3. Any disease that affects sleep quality 5. Any significant acute or chronic disease 6. Previous or current use of psychotropic drugs 7. Consumption of any chemical and herbal medicine for sleep quality disorder 8. Consumption of hormonal pills 9. Having night shift jobs 10. Having stress, anxiety and depression according to the DOS21 scale 11. Sensitivity to basil extract during the study 12. Not taking basil extract capsules for two consecutive days

in The intervention group, capsules containing basil extract will be consumed, and in the control group, capsules containing corn flour will be consumed once a night for a month.

Sleep quality

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 4 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.