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

• Published in: Evidence-based complementary and alternative medicine Vol. 2017; no. 2017; pp. 1 - 10
• Main Authors: Lee, Euiju, Hong, Seung-Ug, Cho, Jae-Heung, Shin, Mi-Ran, Seo, Hyung-Sik, Yu, Ami, Kim, Jinyoung, Shin, Seungwon, Yi, Gilhee
• Format: Journal Article
• Language: English
• Published: Cairo, Egypt Hindawi Publishing Corporation 01.01.2017; Hindawi; John Wiley & Sons, Inc
• Subjects: Analysis; Anxiety; Care and treatment; Chronic illnesses; Clinical trials; Dizziness; Double-blind studies; Evidence-based medicine; Fatigue; Folk medicine; Herbal medicine; Medicine, Primitive; Meniere's disease; Mental depression; Patients; Placebo effect; Placebos; Safety; Vertigo; South Korea
• ISSN: 1741-427X; 1741-4288
• DOI: 10.1155/2017/4363716

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.