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首页> 外文期刊>Evidence-based complementary and alternative medicine: eCAM >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
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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

机译：一种草药，龚济丹，慢性头晕的主体（善良学习）：研究方案，用于前瞻性，多中心，随机，双盲，安慰剂控制，平行群，临床试验，用于有效，安全和成本效益

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摘要

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.
机译：本研究方案旨在探讨草药药物，龙津丹（GJD），慢性头晕患者的有效性，安全性和成本效益。这将是前瞻性，多中心，随机，双盲，安慰剂控制，并行组，临床试验。七十八名患者被诊断出患有Meniere疾病，心理头晕或未知原因的头晕将随机分配给GJD或安慰剂组1：1的比例。参与者将在每天每天服用3.75克GJD或安慰剂，持续56天。主要结果措施将是头晕障碍库存分数。次要结果措施将如下：严重程度（平均眩晕规模和视觉模拟量表）和头晕的频率，平衡功能（Berg平衡标度），疲劳（疲劳严重尺度）和缺乏模式/综合征（齐血yin yang缺陷问卷）水平和抑郁症（韩国版贝克的抑郁库存）和焦虑（国家特质焦虑库存）水平。为了评估安全性，将监测包括实验室测试结果的不良事件。此外，增量成本效益比率将根据质量调整的终身年（来自Euroqol五维'问卷）和医疗费用。数据将以0.05（双面）的显着性水平统计学分析。本试验在2017年7月，在ClincinalTrials.gov NCT03219519注册。

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

  • 作者单位

    Kyung Hee Univ Grad Sch Dept Clin Korean Med 26 Kyungheedae Ro Seoul 02447 South Korea;

    Kyung Hee Univ Grad Sch Dept Clin Korean Med 26 Kyungheedae Ro Seoul 02447 South Korea;

    Kyung Hee Univ Korean Med Clin Trial Ctr Korean Med Hosp 23 Kyungheedae Ro Seoul 02447 South;

    Pusan Natl Univ Sch Korean Med Dept Korean Med Ophthalmol &

    Otolaryngol &

    Dermat 20 Geumo Ro;

    Semyung Univ Dept Sasang Constitut Med Coll Oriental Med 65 Semyung Ro Jecheon 27136;

    Kyung Hee Univ Dept Korean Rehabil Med Coll Korean Med 23 Kyungheedae Ro Seoul 02447 South;

    Dongguk Univ Dept Oriental Med Ophthalmol &

    Otolaryngol &

    Derm Coll Oriental Med 27 Dongguk Ro;

    Dongguk Univ Dept Oriental Med Ophthalmol &

    Otolaryngol &

    Derm Coll Oriental Med 27 Dongguk Ro;

    Kyung Hee Univ Dept Sasang Constitut Med Coll Korean Med 23 Kyungheedae Ro Seoul 02447 South;

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  • 中图分类 临床医学;
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