Acute vestibular syndrome (AVS) (encompassing Ménière's disease, vestibular neuritis, and sudden sensorineural hearing loss with vertigo)
Conditions
Interventions
Intervention Group:Phencynonate Hydrochloride Tablets
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 70 (18 and 70 included), no gender restriction; 2.Acute vestibular syndrome (including Ménière's disease, vestibular neuritis, and sudden sensorineural hearing loss with vertigo), presenting with persistent vertigo of moderate severity or greater (Visual Analogue Scale score >4), with vertigo duration at enrolment of 1 hour < duration <= 24 hours; 3.The patient is conscious, with no impairment in verbal communication, and is able to describe symptoms of vertigo; 4.Blood pressure = 180/110 mmHg at enrolment (to be measured after 5 minutes of rest); 5.Voluntarily sign the information consent form, understanding and agreeing to comply with all research procedures.
Exclusion criteria
Exclusion criteria: 1.Individuals with known hypersensitivity to any component of the investigational medicinal product, or to glucocorticoids or bacillus subtilis; 2.This vertigo is caused by Hunter syndrome, otolithiasis, demyelinating disorders, and cerebrovascular disease; 3.Administration of other anti-vertigo medications such as flunarizine, Vertigostop, betahistine, or betahistine dihydrochloride within 12 hours prior to study enrolment; 4.Presence of impaired consciousness, severe dysarthria, or language dysfunction preventing clear description of vertigo symptoms; 5.Individuals suffering from glaucoma, benign prostatic hyperplasia, or with a history of such conditions; 6.Individuals suffering from severe neurological or psychiatric disorders who are unable to fully comprehend the nature of cooperation. 7.Individuals suffering from severe gastrointestinal disorders affecting drug absorption, distribution, metabolism, and excretion; or those experiencing difficulty swallowing or recurrent vomiting that impedes food intake or medication administration; 8.Exclude individuals with any of the following cardiac conditions within the preceding six months: decompensated heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, myocardial infarction, history of coronary artery bypass grafting (CABG) or coronary stent implantation, uncontrolled or severe arrhythmias such as second- or third-degree atrioventricular block, atrial myxoma, or cardiomyopathy. 9.Individuals with poor glycaemic control are defined as those with fasting blood glucose >11.1 mmol/L, or random blood glucose >13.9 mmol/L, or glycated haemoglobin >9%; 10.Patients with systemic fungal infections, those with bleeding disorders (coagulation disorders, bleeding tendencies due to vascular disorders, active gastrointestinal ulcers, suspected intracranial haemorrhage, thrombocytopenic purpura, haemophilia, menstruation, surgery, urinary tract haemorrhage, haemoptysis, premature birth, miscarriage, women immediately postpartum or in the puerperium with genital bleeding); Patients at risk of haemorrhage (visceral tumours, diverticulitis, colitis, subacute bacterial endocarditis); those currently taking anticoagulants or platelet function inhibitors (e.g., aspirin) or antifibrinolytic agents; recent surgical patients; those with papillary muscle rupture, ventricular septal perforation, cardiogenic shock, or multiple organ failure; 11.History of any of the following major medical conditions, either past or present, that may affect study assessment: History of cranial or extracranial trauma, intracranial tumours, epilepsy, multiple sclerosis; history of malignant tumours (excluding basal cell carcinoma of the skin and cervical carcinoma in situ); history of severe hepatic or renal disease such as cirrhosis, chronic active hepatitis, chronic renal insufficiency; severe haematological disorders (e.g. granulocytopenia, thrombocytopenia, etc.); pheochromocytoma, or active gastric ulcer; 12.Any laboratory test result prior to randomisation meeting the following criteria: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (ULN); serum creatinine (Cr) > 1.5 times ULN; creatine kinase (CK) > 1.5 times ULN; or fibrinogen concentration < 100 mg/dl; 13.Individuals with a history of chronic alcohol abuse or substance misuse; 14.Female participants who are planning to become pregnant, are currently pregnant, or are breastfee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compared with the betahistine mesylate group, the duration of dizziness after medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Tinnitus Handicap Inventory (THI) score from baseline to days 1-5 post-treatment, assessed by blinded investigators, compared with the betahistine mesylate group;Adverse Events;Change in tinnitus and ear fullness symptom severity (VAS score) assessed by blinded investigators at days 1–5 of treatment, compared with the betahistine mesylate group;Improvement in severity of vertigo symptoms (VAS score) from baseline to days 1–5 of treatment, as assessed by blinded investigators, compared with the betahistine mesylate group;Change in the impact of vertigo on daily living score at days 1–5 of treatment, assessed by blinded investigators, compared with the betahistine mesylate group;Change in severity of nausea and vomiting symptoms (VAS score) from baseline to days 1–5 of treatment, as assessed by blinded investigators, compared with the betahistine mesylate group;Change in Dizziness Handicap Inventory (DHI) score from baseline to days 1-5 post-treatment, assessed by blinded investigators, compared with the betahistine mesylate group;Incidence of concomitant use of other anti-vertigo medications during treatment compared with the betahistine mesylate group;Recurrence of vertigo after discontinuation of treatment compared with the betahistine mesylate group (assessed in patients with resolution of vertigo during the treatment period); | — |
Countries
China
Contacts
Public ContactDing Xiuyong
Xuanwu Hospital Capital Medical University
Outcome results
None listed