The purpose of this study is to evaluate the efficacy and safety of isosorbide oral solution compared with placebo in people with unilateral Meniere's disease. A total of approximately 234 subjects will be enrolled in this study: 72 subjects in phase Ⅱ and approximately 162 subjects in phase Ⅲ. Patients were randomly assigned to either the experimental group or the control group. The randomization ratios for phase Ⅱ and phase Ⅲ were 1:1 and 2:1, respectively.
Male or female aged ≥18 and ≤65 years old.
Patients with unilateral Meniere's disease who meet the diagnostic criteria for Meniere's disease in the Guidelines for the Diagnosis and Treatment of Meniere's Disease (2017).
At least 3 episodes of vertigo caused by Meniere's disease within 6 months before enrollment.
Those who understand and voluntarily sign the informed consent.
Patients who have had previous ear surgery for Meniere's disease.
People who suffer from vertigo caused by organic lesions of the external, middle or inner ear.
patients with acute intracranial hematoma;
patients with hypokalemia (serum potassium < lower limit of normal) or severe dehydration (needing infusion, or hospitalization, or life-threatening, requiring emergency treatment);