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IRCT20250308064992N2 IRCT 2025-11-11 Khoram-Abad University of Medical Sciences The effect of Ocimum Basilicum on the sleep quality The effect of Ocimum Basilicum leaf extract on the sleep quality in the female university students 2025-11-22 anticipated 94 Complete https://irct.ir/trial/87384 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 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, 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. 2-3 Sleep quality disorder. Intervention 1: Intervention group: The capsule containing basil extract will be taken once a night for one month. Intervention 2: Control group: The capsule containing corn flour (placebo) will be taken once a night for one month. 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 Negin Rashti
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 neginrashti@gmail.com Khoram-Abad University of Medical Sciences scientific Negin Rashti
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 neginrashti@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) 18-35 years of age single Iranian residing in the dormitory Having sleep quality disorder according to the Pittsburgh questionnaire Body mass index between 18.5 and 35. 18 years 35 years Female consuming alcohol, narcotics, or smoking Drinking more than 4 cups of coffee per day Any disease that affects sleep quality (narcolepsy, obstructive sleep apnea, restless leg syndrome, periodic limb movement syndrome, etc.) Previous (4 weeks prior to study) or current use of psychotropic medications (antiaxiants, sedatives, hypnotics, antipsychotics, antidepressants, centrally acting corticosteroids, and opioid analgesics) Use of any chemical or herbal medicine for sleep quality disorders during the study and 3 months prior to the study Taking hormonal pills Having jobs with night shifts being stressed, anxious or depressed as indicated by DASS21 test Participation in another study during the study and within one month before the intervention sensitivity to basil extract during the study not taking basil extract capsules for two consecutive days F51 Sleep disorders not due to a substance or known physiological condition Treatment - Drugs Placebo Intervention group: The capsule containing basil extract will be taken once a night for one month. Control group: The capsule containing corn flour (placebo) will be taken once a night for one month. Sleep quality. Timepoint: Before the study, one and two weeks after the start of the study. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Khoram-Abad University of Medical Sciences Approved 2025-11-09 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)