Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
78 participants
INTERVENTIONAL
2018-04-01
2020-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Gongjin-dan
Participants will be orally administered Gongjin-dan pills of 3.75g, 1 pill/day, 8 weeks (56 days).
Gongjin-Dan
Gongjin-dan (Iksu Pharmaceutical Co. Ltd, Gwangju, Republic of Korea) is composed of Cervi Parvum, Angelica Gigas Root, Cornus Fruit, Ginseng, Steamed Rehmannia Root, and Musk.
placebo
Participants will be orally administered placebo pills of 3.75g, 1 pill/day, 8 weeks (56 days).
Placebo
Placebo drugs (similar in appearance, taste, and odor to the Gongjin-dan) contains excipients, coloring agents, binders, flavoring agents, and preservative, and gilt-paper covering. Placebo pills of Gongjin-dan will be also made by Iksu Pharmaceutical Co. Ltd, Gwangju, Republic of Korea.
Interventions
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Gongjin-Dan
Gongjin-dan (Iksu Pharmaceutical Co. Ltd, Gwangju, Republic of Korea) is composed of Cervi Parvum, Angelica Gigas Root, Cornus Fruit, Ginseng, Steamed Rehmannia Root, and Musk.
Placebo
Placebo drugs (similar in appearance, taste, and odor to the Gongjin-dan) contains excipients, coloring agents, binders, flavoring agents, and preservative, and gilt-paper covering. Placebo pills of Gongjin-dan will be also made by Iksu Pharmaceutical Co. Ltd, Gwangju, Republic of Korea.
Eligibility Criteria
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Inclusion Criteria
2. Dizziness originating from Ménière disease, psychogenic cause, or unknown cause
3. Recurring symptom of dizziness for more than 1 month
4. Dizziness Handicap Inventory (DHI) score ≥ 24 at baseline
5. Liver-deficiency pattern/syndrome identified by Traditional Korean Medicine doctors
6. Willingness to provide written informed consent
Exclusion Criteria
2. Dizziness attributable to central nervous system (CNS) disorders (e.g., cerebellar ataxia, stroke, demyelination, vertebrobasilar insufficiency, seizure, increased intracranial pressure, Parkinson's disease, migraines, and others)
3. Cervicogenic dizziness
4. Dizziness attributable to cardiovascular disorders (e.g., arrhythmia, heart valvular disease, anemia, orthostatic hypotension, coronary artery disease, and others)
5. Any active or uncontrolled disease that might cause dizziness (e.g., uncontrolled diabetes mellitus, hypertension, respiratory or endocrinological disorders, and others)
6. Dizziness attributable to medication side effects
7. Severe chronic or terminal diseases (malignant cancer, tuberculosis, and others)
8. Intake of other antivertiginous drugs that cannot be discontinued
9. Following physiotherapy, manual therapy (e.g., vestibular rehabilitation), and/or cognitive behavioral therapy for the treatment of dizziness
10. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), or creatinine \> 3 × upper limit of normal range at baseline
11. Women of (suspected) pregnancy or breast-feeding
12. Allergic reactions to the study medications
13. Suspicion of alcohol and/or drug abuse
14. Enrollment in another clinical study presently or within 30 days prior to the initial administration of the study medications
15. Difficulty in reliably communicating with the investigators or likelihood of inability to follow instructions
16. Other reason for ineligibility of participation
20 Years
79 Years
ALL
No
Sponsors
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Kyunghee University
OTHER
Responsible Party
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Lee Eui-ju
Professor, Ph.D. KMD.
Principal Investigators
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Euiju Lee, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University
Locations
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Dongguk University Ilsan Oriental Hospital
Goyang-si, Gyeonggi-do, South Korea
Pusan National University Korean Medicine Hospital
Yangsan, Gyeongsangnam-do, South Korea
Semyung University Korean Medicine Hospital
Chungju, North Chungcheong, South Korea
Kyung Hee University Korean Medicine Hospital
Seoul, Special Seoul City, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Kerber KA, Baloh RW. The evaluation of a patient with dizziness. Neurol Clin Pract. 2011 Dec;1(1):24-33. doi: 10.1212/CPJ.0b013e31823d07b6.
Kroenke K, Lucas CA, Rosenberg ML, Scherokman B, Herbers JE Jr, Wehrle PA, Boggi JO. Causes of persistent dizziness. A prospective study of 100 patients in ambulatory care. Ann Intern Med. 1992 Dec 1;117(11):898-904. doi: 10.7326/0003-4819-117-11-898.
Sokolova L, Hoerr R, Mishchenko T. Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety of Ginkgo biloba Extract EGb 761 and Betahistine. Int J Otolaryngol. 2014;2014:682439. doi: 10.1155/2014/682439. Epub 2014 Jun 25.
Moon E, Her Y, Lee JB, Park JH, Lee EH, Kim SH, Oh MS, Jang CG, Kim SY. The multi-herbal medicine Gongjin-dan enhances memory and learning tasks via NGF regulation. Neurosci Lett. 2009 Dec 11;466(3):114-9. doi: 10.1016/j.neulet.2009.09.033. Epub 2009 Sep 27.
Lee JS, Hong SS, Kim HG, Lee HW, Kim WY, Lee SK, Son CG. Gongjin-Dan Enhances Hippocampal Memory in a Mouse Model of Scopolamine-Induced Amnesia. PLoS One. 2016 Aug 2;11(8):e0159823. doi: 10.1371/journal.pone.0159823. eCollection 2016.
Hong SS, Lee JY, Lee JS, Lee HW, Kim HG, Lee SK, Park BK, Son CG. The traditional drug Gongjin-Dan ameliorates chronic fatigue in a forced-stress mouse exercise model. J Ethnopharmacol. 2015 Jun 20;168:268-78. doi: 10.1016/j.jep.2015.04.001. Epub 2015 Apr 10.
Sunwoo YY, Park SI, Chung YA, Lee J, Park MS, Jang KS, Maeng LS, Jang DK, Im R, Jung YJ, Park SA, Kang ES, Kim MW, Han YM. A Pilot Study for the Neuroprotective Effect of Gongjin-dan on Transient Middle Cerebral Artery Occlusion-Induced Ischemic Rat Brain. Evid Based Complement Alternat Med. 2012;2012:682720. doi: 10.1155/2012/682720. Epub 2012 Jun 6.
Son MJ, Im HJ, Kim YE, Ku B, Lee JH, Son CG. Evaluation of the anti-fatigue effects of a traditional herbal drug, Gongjin-dan, under insufficient sleep conditions: study protocol for a randomised controlled trial. Trials. 2016 Aug 22;17(1):418. doi: 10.1186/s13063-016-1542-7.
Xue Z, Liu CZ, Shi GX, Liu Y, Li ZX, Zhang ZH, Wang LP. Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial. Trials. 2013 Dec 13;14:429. doi: 10.1186/1745-6215-14-429.
Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.
Toupet M, Ferrary E, Grayeli AB. Visual analog scale to assess vertigo and dizziness after repositioning maneuvers for benign paroxysmal positional vertigo. J Vestib Res. 2011;21(4):235-41. doi: 10.3233/VES-2011-0420.
Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
Hewlett S, Dures E, Almeida C. Measures of fatigue: Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF MDQ), Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF NRS) for severity, effect, and coping, Chalder Fatigue Questionnaire (CFQ), Checklist Individual Strength (CIS20R and CIS8R), Fatigue Severity Scale (FSS), Functional Assessment Chronic Illness Therapy (Fatigue) (FACIT-F), Multi-Dimensional Assessment of Fatigue (MAF), Multi-Dimensional Fatigue Inventory (MFI), Pediatric Quality Of Life (PedsQL) Multi-Dimensional Fatigue Scale, Profile of Fatigue (ProF), Short Form 36 Vitality Subscale (SF-36 VT), and Visual Analog Scales (VAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S263-86. doi: 10.1002/acr.20579. No abstract available.
Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol. 2010 Jul;63(7):760-766.e1. doi: 10.1016/j.jclinepi.2009.09.009. Epub 2010 Jan 8.
Staab JP, Ruckenstein MJ. Chronic dizziness and anxiety: effect of course of illness on treatment outcome. Arch Otolaryngol Head Neck Surg. 2005 Aug;131(8):675-9. doi: 10.1001/archotol.131.8.675.
Kim J, Ku B, Kim KH. Validation of the qi blood yin yang deficiency questionnaire on chronic fatigue. Chin Med. 2016 May 2;11:24. doi: 10.1186/s13020-016-0092-y. eCollection 2016.
Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.
Shin S, Kim J, Yu A, Seo HS, Shin MR, Cho JH, Yi G, Hong SU, Lee E. 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. Evid Based Complement Alternat Med. 2017;2017:4363716. doi: 10.1155/2017/4363716. Epub 2017 Dec 13.
Other Identifiers
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HB16C0010-GJD
Identifier Type: -
Identifier Source: org_study_id