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
المؤلفون المشاركون
Lee, Euiju
Yu, Ami
Cho, Jae-Heung
Kim, Jinyoung
Seo, Hyung-Sik
Shin, Mi-Ran
Yi, Gilhee
Hong, Seung-Ug
Shin, Seungwon
المصدر
Evidence-Based Complementary and Alternative Medicine
العدد
المجلد 2017، العدد 2017 (31 ديسمبر/كانون الأول 2017)، ص ص. 1-10، 10ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2017-12-13
دولة النشر
مصر
عدد الصفحات
10
التخصصات الرئيسية
الملخص 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.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Shin, Seungwon& Kim, Jinyoung& Yu, Ami& Seo, Hyung-Sik& Shin, Mi-Ran& Cho, Jae-Heung…[et al.]. 2017. 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. Evidence-Based Complementary and Alternative Medicine،Vol. 2017, no. 2017, pp.1-10.
https://search.emarefa.net/detail/BIM-1153727
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Shin, Seungwon…[et al.]. 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. Evidence-Based Complementary and Alternative Medicine No. 2017 (2017), pp.1-10.
https://search.emarefa.net/detail/BIM-1153727
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Shin, Seungwon& Kim, Jinyoung& Yu, Ami& Seo, Hyung-Sik& Shin, Mi-Ran& Cho, Jae-Heung…[et al.]. 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. Evidence-Based Complementary and Alternative Medicine. 2017. Vol. 2017, no. 2017, pp.1-10.
https://search.emarefa.net/detail/BIM-1153727
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1153727
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر