Evaluation of the effect of Nigella sativa consumption on improving the symptoms of Meniere's disease in Meniere's patients

Determining the effect of Nigella sativa consumption on the improvement of tinnitus in meniere's patients Determining the effect of Nigella sativa consumption on improvement of hearing loss in meniere's patients Determining the effect of Nigella sativa consumption on improvement of dizziness in meniere's patients

Study contains 2 groups of intervention and control. A total of 40 meniere's patients included in the study. This sample size is calculated by STATA software. Patients are divided into two groups by balanced block randomization method with two arms by STATA software. The study is a phase 3 parellel group single-side blind clinical trial with control group

Patients are selected from 2 centers of Amir alam hospital and Dr. Masoud Motasadi ear clinic. They enter the study with single side blind method so that only patients are blinded to the study. The study period is 3 months in which patients in addition to previous basic treatment, receive placebo in control group and Nigella sativa in intervention group

Inclusion criteria: patients who are definite cases of meniere's disease Exclusion criteria: history of cardiac, hepatic, renal, psychiatric and hypertension diseases

Patients in intervention group receive 1 capsule containing 1 gram of Nigella sativa oil daily and in control group receive 1 capsule daily containing 1 gram of placebo orally for 3 months. Patients before entering the study, received half a tablet of Triamterene H 50/25 daily and tablet of Betahistine 16 twice a day. In this study, this previous basic treatment is continued in 2 groups

Hearing loss improvement Tinnitus improvement Dizziness improvement

In order to maintain the balance and equality of the number of people in the study groups, and to prevent the imbalance of the groups, the balanced block randomization method will be used. For this purpose, 10 blocks of four will be considered (n-40) so that in each block, two people will belong to the intervention group and two people will belong to the control group. In each block, the order in which people are assigned to each group will be random, and this process will be repeated for all blocks. So we have 6 possible combinations including AABB, BABA, BAAB, ABAB, ABBA, BBAA (Group A represents the intervention group and group B represents the control group). Finally, based on the available combinations, the letters A and B, which indicate intervention or control, will be written inside the closed envelopes and the number of each patient will be written on the envelopes (The first patient, the second patient, the third patient, and up to the fortieth patient, respectively). An envelope is then opened for each patient who is recruited to determine which group the patient should be assigned to. The randomization process will be performed using STATA16 statistical software.

In this single-blind study, only participants (patients) are blinded. They know that by entering this study, they will be divided into two groups: placebo and medicine, but they do not know in which group they will be placed. But members of the research group such as the principal investigator, analyst, etc. are aware of the distribution of participants into two groups of drug and placebo.