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IRCT20201102049238N1 IRCT 2021-01-13 Tehran University of Medical Sciences The effect of Nigella sativa on Meniere's disease Evaluation of the effect of Nigella sativa consumption on improving the symptoms of Meniere's disease in Meniere's patients 2021-04-06 anticipated 40 Complete https://irct.ir/trial/53458 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Meniere's disease. Intervention 1: Intervention group: capsules containing 1 gram of Nigella sativa oil, oral consumption, 1 gram per day for 3 months, Barij Essence company+ continuation of the previous basic treatment of patients including triamterene H 50/25 (half a tablet daily) and betahistine 16 (twice a day). Intervention 2: Control group: capsules containing 1 gram of placebo, oral consumption, 1 gram per day for 3 months, Barij Essence company+ continuation of the previous basic treatment of patients including triamterene H 50/25 (half a tablet daily) and betahistine 16 (twice a day). 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 The study requires a lot of preparation, such as budgeting and drug production, etc.; thus until all of them are met, no definite decision can be made about when, how and how much to share
public Zahra Rabbani
No.28, Gelayol alley, South Etaati St., Marzdaran Blv.
Tehran Iran (Islamic Republic of) 1464755545 +98 21 8601 3261 z.rabbani1@gmail.com Tehran University of Medical Sciences scientific Dr. Masoud Motasadi Zarandy
No 26, 3rd alley, Vozara St.
Tehran Iran (Islamic Republic of) 1513634111 +98 21 8871 0088 Motasaddi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who are definite cases of Meniere's disease no limit no limit Both History of cardiac disease History of hepatic disease History of renal disease History of psychiatric disease History of hypertension disease H81.09 Meniere's disease, unspecified ear Treatment - Drugs Placebo Intervention group: capsules containing 1 gram of Nigella sativa oil, oral consumption, 1 gram per day for 3 months, Barij Essence company+ continuation of the previous basic treatment of patients including triamterene H 50/25 (half a tablet daily) and betahistine 16 (twice a day) Control group: capsules containing 1 gram of placebo, oral consumption, 1 gram per day for 3 months, Barij Essence company+ continuation of the previous basic treatment of patients including triamterene H 50/25 (half a tablet daily) and betahistine 16 (twice a day) Improvement of tinnitus. Timepoint: At the beginning of the study and 3 months after starting the consumption of Nigella sativa. Method of measurement: Tinnitus Handicap Inventory questionnaire. Improvement of hearing loss. Timepoint: At the beginning of the study and 3 months after starting the consumption of Nigella sativa. Method of measurement: Audiometry. Improvement of vertigo. Timepoint: At the beginning of the study and 3 months after starting the consumption of Nigella sativa. Method of measurement: Dizziness Handicap Inventory questionnaire. Tehran University of Medical Sciences Approved 2021-01-04 Ethics Committee in Research of Amir Alam Hospital Complex North Saadi St., Enghelab St. Tehran Tehran Iran (Islamic Republic of)