A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study)‎: Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness

Abstract EN

This study protocol aims to explore the effectiveness, safety, and cost-effectiveness of a herbal medication, Gongjindan (GJD), in patients with chronic dizziness.

This will be a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, clinical trial.

Seventy-eight patients diagnosed with Meniere’s disease, psychogenic dizziness, or dizziness of unknown cause 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 GJD or placebo in pill form once a day for 56 days.

The primary outcome measure will be the Dizziness Handicap Inventory score.

Secondary outcome measures will be as follows: severity (mean vertigo scale and visual analogue scale) and frequency of dizziness, balance function (Berg Balance Scale), fatigue (Fatigue Severity Scale) and deficiency pattern/syndrome (qi blood yin yang-deficiency questionnaire) levels, and depression (Korean version of Beck’s Depression Inventory) and anxiety (State-Trait Anxiety Inventory) levels.

To assess safety, adverse events, including laboratory test results, will be monitored.

Further, the incremental cost-effectiveness ratio will be calculated based on quality-adjusted life years (from the EuroQoL five dimensions’ questionnaire) and medical expenses.

Data will be statistically analyzed at a significance level of 0.05 (two-sided).

This trial is registered with ClinicalTrials.gov NCT03219515, in July 2017.