Investigating the effect of Basil (Ocimum Basilicum) capsules on severity of premenstrual syndrome symptoms in students of the Kermanshah university of medical sciences: a randomized, Triple-blind, placebo-controlled study

Determining the effect of Basil (Ocimum Basilicum) capsules on severity of premenstrual syndrome symptoms

A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 84patients. Random block method will be used for randomization.

The current study is a three-blind randomized clinical trial (participant, researcher, outcome evaluator and data analyst not informed about the received treatment) in which the effect of oral basil capsules on the severity of premenstrual syndrome symptoms in students of the University of Medical Sciences Kermanshah will be investigated.

living in the dormitory of Kermanshah University of Medical Sciences, suffering from premenstrual syndrome, physical and mental health, not taking hormonal and coagulation drugs, antidepressants and herbal drugs

The intervention group will receive one 300 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.

Premenstrual syndrome symptoms

In this study, samples will be studied in each of the groups by using a random block of 4 that will be created using the website https://www.sealedenvelope.com. For this purpose, before starting the sampling, the following things will be considered regarding the implementation of the random assignment process: a) a block of 4 will be considered b) a name will be assigned to each of the groups, for example A to the intervention group, B to Placebo group, c) a sequence will be created for a sample size of 100. d) for the concealment process of the random allocation process, 25 non-transparent envelopes and 100 cards will be created, with the block number on each envelope and the name of the desired group on each card It will be written in sequence. In other words, four cards are placed in each envelope in order of sequence. e) Steps A to D will be carried out by the researcher and will be assigned to the person who evaluates the patients according to the entry and exit criteria and assigns them to the groups.

The drug and the placebo are placed in the same packaging and envelopes with consecutive numbering by the pharmacist and coded by the pharmacist with 2 codes (code A for basil capsule and code B for placebo). Entering people into the study and delivering the envelopes will be done by the researcher. 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.