Efficacy and Safety of Isosorbide Oral Solution in Patients With Meniere's Disease

Inclusion criteria

• 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.

Exclusion criteria

• 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 diseases that the investigators believe may limit the subjects' participation in this trial:

• 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);
• patients with acute pulmonary edema;
• patients with hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <60 mmHg during the screening period);
• patients with severe cardiovascular and cerebrovascular diseases: such as New York Heart Association grade III or IV heart failure, myocardial infarction or unstable angina pectoris within the last 6 months, severe heart failure, progressive multifocal leukoencephalopathy, hypertension that is difficult to control with drugs (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥100 mmHg), etc.;
• patients with major diseases of other important organs that affect their participation in this study.
• Patients who need to use diuretics other than trial drugs for a long time after enrollment.
• Patients with any of the following conditions are known or found in laboratory tests:

• serum creatinine (Cr) level is not within the normal range;
• human immunodeficiency virus (HIV) test is positive or has acquired immunodeficiency syndrome (AIDS);
• active syphilis infection (positive Treponema pallidum antibody and positive non-specific syphilis antibody);
• active hepatitis, hepatitis B: HBsAg and/or HBcAb are positive and HBV-DNA > 500 IU/mL or the lower limit of detection of the research center [only when the lower limit of detection of the research center is higher than 500 IU/mL]; hepatitis C: HCV antibody is positive and HCV-RNA is positive or greater than the upper limit of normal value.
• Patients with known or suspected history of allergy to the investigational drug (isosorbide) and its excipients (sorbitol, lactic acid, saccharin sodium, propylparaben, butylparaben, orange flavor).
• Those with a history of drug abuse or alcoholism within 6 months before enrollment.
• Patients who have taken any prohibited drugs specified in this protocol for more than 1 week within 4 weeks before the first administration, including but not limited to vestibular suppressants (including antihistamines - promethazine, diphenhydramine, chlorpheniramine, etc., benzodiazepines - diazepam, lorazepam, clonazepam, etc., anticholinergics - scopolamine, atropine, glycopyrrolate, etc., and antidopamines - prochlorperazine, droperidol, etc.), betahistine, diuretics (including thiazide diuretics - hydrochlorothiazide, chlorthalidone, indapamide, indapamide sustained-release tablets, etc., loop diuretics - furosemide, torsemide, etc., potassium-sparing diuretics - amiloride, triamterene, etc.), glucocorticoids (including prednisone, methylprednisolone, betamethasone, beclomethasone propionate, prednisolone, hydrocortisone, dexamethasone, etc.).
• Those who received intratympanic injection of gentamicin within the last year.
• Patients who have received any other clinical trial drugs/devices within 30 days before the first dose.
• Pregnant or lactating women, female patients or male patients' partners who plan to become pregnant during the study period and within 6 months after the last dose, and those who are unwilling to use a medically recognized effective contraceptive method (such as intrauterine contraceptive device or condom) during the trial.
• Those who are judged by the researchers to be unsuitable for inclusion.