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Meniere's Disease | Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease

Meniere's Disease research study

What is the primary objective of this study?

Meniere's disease is a chronic illness that affects a substantial number of patients every year worldwide. The disease is characterized by intermittent episodes of vertigo lasting from minutes to hours, with fluctuating sensorineural hearing loss, tinnitus, and aural pressure. It has recently been suggested that viral etiologies specially Herpes virus might be the underlying reason. The investigators study is a randomized, double- blinded placebo-controlled clinical trial in Amiralam Hospital. In this study the primary objective is to assess efficacy of Acyclovir in control of symptoms in patients with Meniere's disease specially their vertigo attacks. Inclusion criteria would be patient's willingness to participate in the study and follow ups, being 18 years old or older, having at least 2 vertigos per month each at least 20 min, interfering with function, and not on medication for Meniere's disease for at least 3 months before the trial. They should not have any history of allergy to Acyclovir, renal insufficiency or Creatinine above 1.5 mg/dl, hepatic enzymes more than three times normal, serious uncontrolled illness, be pregnant or nursing or have previous surgeries on Endolymphatic Sac. Participants will be randomly placed in 2 different arms getting either Acyclovir 400 mg or placebo (inert ingredient). They will take the medication 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 will report changes in their symptoms 10 days after initiating the drug and in 1, 3, 6 month intervals.

Who is eligible to participate?

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 min, 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Meniere's Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AcyclovirPatients who were randomly allocated to the Acyclovir group besides sticking with low salt diet will take the Acyclovir 400 mg pills 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 way it would boost their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, and 6 month intervals. 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.

Drug:PlaceboParticipants who are randomly placed in placebo group, besides sticking with low salt diet will take the placebo (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 way it would boost their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, and 6 month intervals. 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

AcyclovirAcyclovir 400 mg tablets by mouth 5 times a day for the first month, 3 times a day for next 10 days, and 2 times a day for the last 10 days.

PlaceboPlacebo tablets by mouth 5 times a day for the first month, 3 times a day for next 10 days, and 2 times a day for the last 10 days.

Study Status

Unknown status

Start Date: August 2011

Completed Date:

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Vertigo

Secondary Outcome: Hearing Loss

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Tehran University of Medical Sciences

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01729767

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