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Evidence-Based Complementary and Alternative Medicine
Volume 2017, Article ID 4363716, 10 pages
https://doi.org/10.1155/2017/4363716
Research Article

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

1Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea
2Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea
3Department of Korean Medical Ophthalmology & Otolaryngology & Dermatology, School of Korean Medicine, Pusan National University, 20 Geumo-ro, Mulgeum-eup, Yangsan, Gyeongsangnam-do 50612, Republic of Korea
4Department of Sasang Constitutional Medicine, College of Oriental Medicine, Semyung University, 65 Semyung-ro, Jecheon, Chungcheongbuk-do 27136, Republic of Korea
5Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea
6Department of Oriental Medicine Ophthalmology & Otolaryngology & Dermatology, College of Oriental Medicine, Dongguk University, 27 Dongguk-ro, Ilsandong-gu, Goyang, Gyeonggi-do 10326, Republic of Korea
7Department of Sasang Constitutional Medicine, College of Korean Medicine, Kyung Hee University, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea

Correspondence should be addressed to Seung-Ug Hong; ten.liamnah@ushtneeh and Euiju Lee; ten.muad@nignasas

Received 16 July 2017; Accepted 19 October 2017; Published 13 December 2017

Academic Editor: Carmen Mannucci

Copyright © 2017 Seungwon Shin et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.