Peripheral vertigo[benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular neuritis]
Conditions
Interventions
experimental group:Banxia Tianma Wan
control group:Banxia Tianma Wan placebo
Sponsors
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) age between 18-70 years old, regardless of gender; (2) It was in accordance with the TCM diagnostic criteria of peripheral vertigo, and the syndrome type was in accordance with the obstruction type of phlegm (mainly manifested as one or several items of dizziness, nausea and vomiting, fatigue with less food, and greasy coating). (3) meeting the Western medicine diagnostic criteria of peripheral vertigo [benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular neuritis], the degree of vertigo was moderate [visual analogue scale (VAS) score of 4-6 (including boundary value) and patients had vertigo symptoms at the time of inclusion]; (4) All subjects voluntarily signed informed consent; (5) The subjects were able to maintain good communication with the investigators and comply with various requirements of the clinical trial.
Exclusion criteria
Exclusion criteria: (1) malignant or dangerous vertigo; (2) Non-vestibular vertigo (ocular, cervical, systemic diseases, hematological diseases, kidney, endocrine and metabolic diseases, such as cervical spondylosis, vertebrobasilar vascular disease, cerebral arteriosclerosis, acoustic neuroma, hypertension, anemia, arrhythmia, etc.), acute vestibular vertigo, and no vestibular function damage symptoms after acute vestibular vertigo; (3) acute hemorrhage of brain stem and cerebellum, arachnoiditis, meningitis, brain abscess, brain stem tumor, brain stem encephalitis and other dangerous central vertigo; (4) Other types of vertigo, such as central vertigo, psychological vertigo, drug-induced vertigo, and other vertigo with unknown causes; (5) The TCM diagnosis of vertigo was liver-yang hyperactivity type, qi and blood deficiency type, kidney essence deficiency type, blood stasis blocking orifices type; (6) Drugs that interfere with efficacy evaluation, such as anti-vertigo drugs, antihistamines, sedatives, drugs for promoting blood circulation and removing blood stasis, or drugs for improving microcirculation, which were taken twice or more in a week before enrollment or taken within 12 hours before enrollment or planned to be used during the study; (7) combined with severe cervical spine disease, severe cardiovascular disease, cerebrovascular disease (such as carotid artery stenosis) and other inner ear diseases except peripheral vertigo; (8) unable to cooperate with the researchers due to conscious or mental disorders; (9) patients with obvious depression, severe neurological deficits, such as coma, aphasia, visual and hearing impairment; (10) patients who are unable to swallow oral drugs or have diseases that affect the absorption of oral drugs, such as active bowel disease, partial or complete intestinal obstruction, etc.; (11) current or previous heavy alcohol use (defined as mean > intake in men over a continuous period of more than 3 months; 210 g/ week, women > 140 g/ week) or inability to reliably quantify alcohol consumption in the past 5 years, as judged by the investigator; (12) patients with known history of allergy to test drug components or similar drugs, history of allergic diseases or allergic constitution; (13) were enrolled in other clinical trials or enrolled in other drug trials within 3 months before screening; (14) diseases of circulatory, respiratory, urinary, digestive, hematopoietic system (such as unstable angina pectoris, uncontrolled asthma, bronchial asthma, active gastric ulcer, gastrointestinal ulcer, active gastric bleeding, etc.) and cancer (such as pheochromocytoma); (15) Hepatitis B surface antigen positive or human immunodeficiency virus antibody /P24 antigen positive or syphilis specific antibody positive or hepatitis C virus antibody positive; (16) blood donation including blood components, massive blood loss (=400mL), transfusion or use of blood products within 2 months before screening; (17) women who are pregnant or lactating, or men or women of childbearing potential who do not want to use contraception during the trial while taking the study drug until 6 months after discontinuation; (18) The investigator considered the patient to have any other factors that could affect the efficacy or safety evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total effective rate of the two groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of Traditional Chinese Medicine Syndrome Score before and after Treatment;Improvement of perceived dizziness score before and after treatment [Visual Analog Scale (VAS) 0-10 points];Improvement of the Dizziness Disorder Inventory (DHI) score;Frequency of dizziness attacks (times/week);Duration of dizziness attack (seconds);University of California, Los Angeles Dizziness Questionnaire (UCLA-DQ);Evaluate the time when the subject's dizziness symptoms disappear; | — |
Countries
China
Contacts
Public ContactRuan Yan
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Outcome results
None listed