This study protocol aims to explore the effectiveness, safety, and cost-effectiveness of a herbal medication, Gongjindan (GJD), in\npatients with chronic dizziness. This will be a prospective, multicenter, randomized, double-blind, placebo-controlled, parallelgroup,\nclinical trial. Seventy-eight patients diagnosed with Meniere�s disease, psychogenic dizziness, or dizziness of unknown\ncause will be randomized and allocated to either a GJD or a placebo group in a 1 : 1 ratio. Participants will be orally given 3.75 g\nGJD or placebo in pill form once a day for 56 days. The primary outcome measure will be the Dizziness Handicap Inventory\nscore. Secondary outcome measures will be as follows: severity (mean vertigo scale and visual analogue scale) and frequency\nof dizziness, balance function (Berg Balance Scale), fatigue (Fatigue Severity Scale) and deficiency pattern/syndrome (qi blood\nyin yang-deficiency questionnaire) levels, and depression (Korean version of Beck�s Depression Inventory) and anxiety (State-\nTrait Anxiety Inventory) levels. To assess safety, adverse events, including laboratory test results, will be monitored. Further, the\nincremental cost-effectiveness ratio will be calculated based on quality-adjusted life years (from the EuroQoL five dimensions�\nquestionnaire) and medical expenses. Data will be statistically analyzed at a significance level of 0.05 (two-sided). This trial is\nregistered with ClinicalTrials.gov NCT03219515, in July 2017.
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