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

Seungwon Shin, Jinyoung Kim, Ami Yu, Hyung-Sik Seo, Mi-Ran Shin, Jae-Heung Cho, Gilhee Yi, Seung-Ug Hong, Euiju Lee, Seungwon Shin, Jinyoung Kim, Ami Yu, Hyung-Sik Seo, Mi-Ran Shin, Jae-Heung Cho, Gilhee Yi, Seung-Ug Hong, Euiju Lee

Abstract

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.

Figures

Figure 1
Figure 1
Study flowchart. BBS, Berg Balance Scale; BI, Blinding Index; CNS, central nervous system; DHI, Dizziness Handicap Inventory; EQ-5D, EuroQoL five dimensions' questionnaire; FSS, Fatigue Severity Scale; GJD, Gongjindan; GPE, Global perceived effect; K-BDI, Korean version of Beck's Depression Inventory; MVS, mean vertigo scale; QBYY-Q, qi blood yin yang-deficiency questionnaire; STAI, State-Trait Anxiety Inventory; VAS, visual analogue scale; wks, weeks; yr, year.

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