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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138901023597N1
Enrollment
80
Registered
2012-11-20
Start date
2011-08-02
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniere's disease. Labyrinthine hydrops Ménière's syndrome or vertigo

Interventions

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 n
Placebo
Treatment - Drugs
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
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

Sponsors

Vice Chancellor of Research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Vertigo. Timepoint: Before intervention, 1 month, 3 months and 6 months after the intervention. Method of measurement: Subjective.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Masoud Motesadi

Amiralam Hospital, Tehran University of Medical Sciences

motesadi@sina.tums.ac.ir+98 21 6672 4777

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026