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IRCT20230913059428N1 IRCT 2023-10-09 Tabriz University of Medical Sciences Rizatriptan versus Betahistin in Vestibular Migraine treatment A clinical trial of sublingual Rizatriptan versus oral Betahistin in acute phase treatment of vertigo in patients suffering from vestibular migraine 2023-10-23 anticipated 40 Complete https://irct.ir/trial/73034 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples eligible for study will be randomly assigned to two treatment groups with oral rizatriptan or Betahistine treatment using www.Randomization.com, Blinding description: Both the patients and all the researchers (ear, nose and throat specialist, neurologist, neurology resident, statistical consultant) will be unaware of the patient's exposure (Betahistine or Rrizatriptan). 3 Condition 1: vestibular migraine. Condition 2: vestibular migraine. Intervention 1: Intervention group: (The first intervention group) patients in this group will receive oral rizatriptan 10 mg (Farabi Pharmaceuticals) once as a stat dose. Intervention 2: Intervention group: (second intervention group): Patients of this group will receive oral Betahistine 8 mg (Actoverco Pharmaceuticals) once as a stat dose. 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 Venus Ghaffarzadeh Farid
No.74,Dastmalchi Alley., Abbasi Ave., , Tabriz
Tabriz Iran (Islamic Republic of) 5155831734 +98 41 3658 2544 v.ghaffarzadeh@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Venus Ghaffarzadeh Farid
No.74,Dastmalchi Alley., Abbasi Ave., , Tabriz
Tabriz Iran (Islamic Republic of) 5155831734 +98 41 3658 2544 v.ghaffarzadeh@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Including the International Headache Society criteria for vestibular migraine Acute vertigo with moderate to severe intensity 18 years 65 years Both Patients with suspected vestibular disorders other than vestibular migraine Patients with a suspected history of Orthostatic Hypotension or panic disorders history of basilar or hemiplegic migraine Presence of severe kidney or liver disorders Symptoms suggestive of ischemic heart disease history of HTN history of previous TIA/stoke history of drug or substance or alcohol abuse Systolic blood pressure above 160 or diastolic blood pressure above 90 pregnancy G43 H81.8X Migraine Other disorders of vestibular function Treatment - Drugs Treatment - Drugs Intervention group: (The first intervention group) patients in this group will receive oral rizatriptan 10 mg (Farabi Pharmaceuticals) once as a stat dose. Intervention group: (second intervention group): Patients of this group will receive oral Betahistine 8 mg (Actoverco Pharmaceuticals) once as a stat dose. Dizziness intensity. Timepoint: At the beginning of the study (before the start of the intervention) and 4 and 24 hours after taking the drug. Method of measurement: Compiled questionnaire. Tabriz University of Medical Sciences Approved 2023-10-07 Working group/committee of ethics in research of Tabriz University of Medical Sciences No.74,Dastmalchi Alley., Abbasi Ave., , Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)