]>
IRCT138901023597N1 IRCT 2012-11-20 Vice Chancellor of Research, Tehran University of Medical Sciences Efficacy of antiviral medications in controlling vertigo attacks of patients with Meniere's Disease Assessment of Acyclovir efficacy versus placebo in controlling vertigo attacks of patients with Meniere's Disease visited in Amiralam hospital 2011-08-02 anticipated 80 Complete https://irct.ir/trial/3700 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This clinical trial is double blind and neither the patients nor the researchers know who belongs to the placebo arm and who belongs to the Acyclovir arm. Randomization method is block randomization. Only after all the data have been recorded do the researchers learn which individuals are which. In this way researchers will not be biased in their assessment of patients response to the treatment given. Patients in Acyclovir arm will receive Acyclovir 400 mg pills (Zovirax), and the placebo in this study mainly consists of calcium phosphate and Avicel (microcrystalline cellulose ). Placebo and Acyclovir pills used in this study are all provided by Farabi Pharmaceutical Company and will be handed to patients in similar pill bottels. 2-3 Meniere's disease. Intervention 1: Participants who are randomly placed in placebo group, besides having a low salt diet will take the placebo pills (inert ingredient) for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. Patients would receive the medication in 2 sessions, first in the beginning of the study and the rest after 10 days. This would increase their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and one month, three months and six months after the treatment. All changes in frequency and duration of vertigo attacks are recorded, and tinnitus and aural fullness is recorded in a 0(with no symptom) to 4 (very severe) scale. Intervention 2: Patients who were randomly allocated to the Acyclovir group besides having low salt diet will take the Acyclovir 400 mg pills (Zovirax) for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. Patients would receive the medication in 2 sessions, first in the beginning of the study and the rest after 10 days. This would increase their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and one month, three months and six months after the treatment. All changes in frequency and duration of vertigo attacks are recorded, and their tinnitus and aural fullness is recorded in a 0(with no symptom) to 4 (very severe) scale.
public Dr Masoud Motesadi
Tehran, Enghelab Avenue, North Saadi Avenue, Opposite Bank of Commerce
Tehran Iran (Islamic Republic of) +98 21 6672 4777 motesadi@sina.tums.ac.ir Amiralam Hospital, Tehran University of Medical Sciences scientific Dr Masoud Motesadi
Tehran, Enghelab Avenue, North Saadi Avenue, Opposite Bank of Commerce
Tehran Iran (Islamic Republic of) +98 21 6672 4777 motesadi@sina.tums.ac.ir Tehran University of Medical Sciences, Amiralam Hospital Iran (Islamic Republic of) Inclusion criteria:1. Patients' willingness to participate in the study 2. Willingness to participate in follow ups 3. Age of 18 or older 4. Having at least 2 vertigos per month each lasting for at least 20 minutes, severely interfering with function 5. Not on medication for at least 3 months before starting the trial. Exclusion Criteria: 1. History of Allergy to Acyclovir or the drugs in the same category 2. Renal insufficiency or having Creatinine more than 1.5 mg/dl 3. Hepatic enzymes more than 3 times normal 4. Hematocrit less than 30% 5. Thrombocytopenia 6. Having a serious uncontrolled illness 7. Pregnant or nursing ladies 8. Using Probenecid 9. Previous surgeries on endolymphatic sac. 18 years 85 years Both H81.0 Labyrinthine hydrops Ménière's syndrome or vertigo Placebo Treatment - Drugs Participants who are randomly placed in placebo group, besides having a low salt diet will take the placebo pills (inert ingredient) for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. Patients would receive the medication in 2 sessions, first in the beginning of the study and the rest after 10 days. This would increase their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and one month, three months and six months after the treatment. All changes in frequency and duration of vertigo attacks are recorded, and tinnitus and aural fullness is recorded in a 0(with no symptom) to 4 (very severe) scale. Patients who were randomly allocated to the Acyclovir group besides having low salt diet will take the Acyclovir 400 mg pills (Zovirax) for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. Patients would receive the medication in 2 sessions, first in the beginning of the study and the rest after 10 days. This would increase their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and one month, three months and six months after the treatment. All changes in frequency and duration of vertigo attacks are recorded, and their tinnitus and aural fullness is recorded in a 0(with no symptom) to 4 (very severe) scale. Vertigo. Timepoint: Before intervention, 1 month, 3 months and 6 months after the intervention. Method of measurement: Subjective. Aural fullness. Timepoint: Before intervention, 1 month, 3 months and 6 months after the intervention. Method of measurement: Subjective evaluation in a 0(with no symptom) to 4 (very severe) scale. Incidence of patients experiencing nausea as side effect. Timepoint: Before intervention, 1 month, 3 months and 6 months after the intervention. Method of measurement: Patient's subjective evaluation. Tinnitus. Timepoint: Before intervention, 1 month, 3 months and 6 months after the intervention. Method of measurement: Subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale. Change in renal function as a side effect. Timepoint: Before intervention, 1 month, 3 months and 6 months after the intervention. Method of measurement: Renal function test , if history suggestive of that. Hearing. Timepoint: Before intervention, 1 month, 3 months and 6 months after the intervention. Method of measurement: Audiometry and also subjective evaluation. Vice Chancellor of Research, Tehran University of Medical Sciences Approved 2010-12-20 Medical ethics committee of Tehran University of Medical Sciences No. 23, 16 Azar St., Keshavarz Blvd., Tehran Tehran Iran (Islamic Republic of)