Back to resultsHerbal Medication (Gongjin-dan) for Chronic Dizziness (GOODNESS)
Primary Purpose
Dizziness Chronic
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gongjin-Dan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dizziness Chronic
Eligibility Criteria
Inclusion Criteria:
- Age between 20 and 79 years, of either sex
- Dizziness originating from Ménière disease, psychogenic cause, or unknown cause
- Recurring symptom of dizziness for more than 1 month
- Dizziness Handicap Inventory (DHI) score ≥ 24 at baseline
- Liver-deficiency pattern/syndrome identified by Traditional Korean Medicine doctors
- Willingness to provide written informed consent
Exclusion Criteria:
- Dizziness attributable to vestibular disorders (e.g., benign paroxysmal positional vertigo, peripheral vestibulopathy, labyrinthitis, vestibular neuronitis, and others)
- 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)
- Cervicogenic dizziness
- Dizziness attributable to cardiovascular disorders (e.g., arrhythmia, heart valvular disease, anemia, orthostatic hypotension, coronary artery disease, and others)
- Any active or uncontrolled disease that might cause dizziness (e.g., uncontrolled diabetes mellitus, hypertension, respiratory or endocrinological disorders, and others)
- Dizziness attributable to medication side effects
- Severe chronic or terminal diseases (malignant cancer, tuberculosis, and others)
- Intake of other antivertiginous drugs that cannot be discontinued
- Following physiotherapy, manual therapy (e.g., vestibular rehabilitation), and/or cognitive behavioral therapy for the treatment of dizziness
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), or creatinine > 3 × upper limit of normal range at baseline
- Women of (suspected) pregnancy or breast-feeding
- Allergic reactions to the study medications
- Suspicion of alcohol and/or drug abuse
- Enrollment in another clinical study presently or within 30 days prior to the initial administration of the study medications
- Difficulty in reliably communicating with the investigators or likelihood of inability to follow instructions
- Other reason for ineligibility of participation
Sites / Locations
- Semyung University Korean Medicine Hospital
- Dongguk University Ilsan Oriental Hospital
- Pusan National University Korean Medicine Hospital
- Kyung Hee University Korean Medicine Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gongjin-dan
placebo
Arm Description
Participants will be orally administered Gongjin-dan pills of 3.75g, 1 pill/day, 8 weeks (56 days).
Participants will be orally administered placebo pills of 3.75g, 1 pill/day, 8 weeks (56 days).
Outcomes
Primary Outcome Measures
Dizziness Handicap Inventory (DHI), change between baseline and endpoint
Assessment of the impairment caused by dizziness
Secondary Outcome Measures
Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42
Assessment of the impairment caused by dizziness
Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56
Assessment of the intensity of dizziness
Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56
Assessment of the intensity of dizziness
Frequency of episodes (dizziness), changes between baseline and day 28 and day 56
The frequency score of dizziness
Berg Balance Scale (BBS), changes between baseline and day 28 and day 56
Assessment of the balance impairment
Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56
Assessment of the severity of chronic fatigue
Global Perceived Effect (GPE)
Assessment of a patient's perception of symptom worsening or improvement, Patient-rated outcome, 1 item, 1-7 scores
Korean version of Beck Depression Inventory (K-BDI), changes between baseline and day 28 and day 56
Assessment of the severity of depression
State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56
Assessment of the severity of anxiety
Qi Blood Yin Yang deficiency questionnaire (QBYY-Q), changes between baseline and day 28 and day 56
Assessment of the level of deficiency pattern/syndrome in traditional Korean medicine
EuroQol five-dimensions questionnaire five-level (EQ-5D-5L), changes between baseline and each assessment
Assessment of the level of quality of life
EuroQol five dimensions questionnaire visual analogue scale (EQ VAS), change between baseline and each assessment
Assessment of the level of quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03219515
Brief Title
Herbal Medication (Gongjin-dan) for Chronic Dizziness
Acronym
GOODNESS
Official Title
Safety, Effectiveness, and Cost-effectiveness of an Herbal Medicine, Gongjin-dan, in Subjects With Chronic Dizziness: a Prospective, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Anticipated)
Primary Completion Date
August 30, 2020 (Anticipated)
Study Completion Date
August 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group, clinical trial to explore the effectiveness of an herbal medication, Gongjin-dan (GJD) for chronic dizziness (Ménière disease, psychogenic dizziness, or dizziness of unknown cause), identified as liver-deficiency pattern/syndrome, and assessed with Dizziness Handicap Inventory (DHI) ≥ 24 at baseline. Participants will be randomized and allocated to either GJD or placebo group with 1:1 ratio and orally administered GJD or placebo pills once a day for 8 weeks. For collecting data for cost-effectiveness analysis, the participants will be followed up to 12 months from randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gongjin-dan
Arm Type
Experimental
Arm Description
Participants will be orally administered Gongjin-dan pills of 3.75g, 1 pill/day, 8 weeks (56 days).
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be orally administered placebo pills of 3.75g, 1 pill/day, 8 weeks (56 days).
Intervention Type
Drug
Intervention Name(s)
Gongjin-Dan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dizziness Handicap Inventory (DHI), change between baseline and endpoint
Description
Assessment of the impairment caused by dizziness
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42
Description
Assessment of the impairment caused by dizziness
Time Frame
14 days
Title
Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56
Description
Assessment of the intensity of dizziness
Time Frame
28 days
Title
Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56
Description
Assessment of the intensity of dizziness
Time Frame
28 days
Title
Frequency of episodes (dizziness), changes between baseline and day 28 and day 56
Description
The frequency score of dizziness
Time Frame
28 days
Title
Berg Balance Scale (BBS), changes between baseline and day 28 and day 56
Description
Assessment of the balance impairment
Time Frame
28 days
Title
Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56
Description
Assessment of the severity of chronic fatigue
Time Frame
28 days
Title
Global Perceived Effect (GPE)
Description
Assessment of a patient's perception of symptom worsening or improvement, Patient-rated outcome, 1 item, 1-7 scores
Time Frame
Day 56
Title
Korean version of Beck Depression Inventory (K-BDI), changes between baseline and day 28 and day 56
Description
Assessment of the severity of depression
Time Frame
28 days
Title
State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56
Description
Assessment of the severity of anxiety
Time Frame
28 days
Title
Qi Blood Yin Yang deficiency questionnaire (QBYY-Q), changes between baseline and day 28 and day 56
Description
Assessment of the level of deficiency pattern/syndrome in traditional Korean medicine
Time Frame
28 days
Title
EuroQol five-dimensions questionnaire five-level (EQ-5D-5L), changes between baseline and each assessment
Description
Assessment of the level of quality of life
Time Frame
Day 0, Day 28, Day 56, Month 4, Month 8, Month 12
Title
EuroQol five dimensions questionnaire visual analogue scale (EQ VAS), change between baseline and each assessment
Description
Assessment of the level of quality of life
Time Frame
Day 0, Day 28, Day 56, Month 4, Month 8, Month 12
Other Pre-specified Outcome Measures:
Title
Medical expenses on dizziness
Description
medical and non-medical expenses to treat dizziness for estimating the incremental cost-effectiveness ratio
Time Frame
Day 14, Day 28, Day 42, Day 56, Month 4, Month 8, Month 12
Title
New Blinding index (New BI)
Description
Blinding assessment
Time Frame
Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 20 and 79 years, of either sex
Dizziness originating from Ménière disease, psychogenic cause, or unknown cause
Recurring symptom of dizziness for more than 1 month
Dizziness Handicap Inventory (DHI) score ≥ 24 at baseline
Liver-deficiency pattern/syndrome identified by Traditional Korean Medicine doctors
Willingness to provide written informed consent
Exclusion Criteria:
Dizziness attributable to vestibular disorders (e.g., benign paroxysmal positional vertigo, peripheral vestibulopathy, labyrinthitis, vestibular neuronitis, and others)
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)
Cervicogenic dizziness
Dizziness attributable to cardiovascular disorders (e.g., arrhythmia, heart valvular disease, anemia, orthostatic hypotension, coronary artery disease, and others)
Any active or uncontrolled disease that might cause dizziness (e.g., uncontrolled diabetes mellitus, hypertension, respiratory or endocrinological disorders, and others)
Dizziness attributable to medication side effects
Severe chronic or terminal diseases (malignant cancer, tuberculosis, and others)
Intake of other antivertiginous drugs that cannot be discontinued
Following physiotherapy, manual therapy (e.g., vestibular rehabilitation), and/or cognitive behavioral therapy for the treatment of dizziness
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), or creatinine > 3 × upper limit of normal range at baseline
Women of (suspected) pregnancy or breast-feeding
Allergic reactions to the study medications
Suspicion of alcohol and/or drug abuse
Enrollment in another clinical study presently or within 30 days prior to the initial administration of the study medications
Difficulty in reliably communicating with the investigators or likelihood of inability to follow instructions
Other reason for ineligibility of participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Euiju Lee, Ph.D.
Phone
+8229589230
Email
sasangin@daum.net
First Name & Middle Initial & Last Name or Official Title & Degree
Seungwon Shin, M.D.
Phone
+8229589730
Email
ssw.kmd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Euiju Lee, Ph.D.
Organizational Affiliation
Kyunghee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semyung University Korean Medicine Hospital
City
Chungju
State/Province
Chungcheongbuk-do
ZIP/Postal Code
27429
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi-Ran Shin, Ph.D.
Phone
+82 43-841-1734
Email
shinmr19@hanmail.net
Facility Name
Dongguk University Ilsan Oriental Hospital
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
10326
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Ug Hong, Ph.D.
Phone
+82-31-961-9085
Email
heenthsu@hanmail.net
Facility Name
Pusan National University Korean Medicine Hospital
City
Yangsan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung-Sik Seo, Ph.D.
Phone
+82 55-360-5630
Email
aran99@naver.com
Facility Name
Kyung Hee University Korean Medicine Hospital
City
Seoul
State/Province
Special Seoul City
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eui-ju Lee, Ph.D.
Phone
+8229589230
Email
sasangin@daum.net
First Name & Middle Initial & Last Name & Degree
Seungwon Shin, M.D.
Phone
+829589730
Email
ssw.kmd@gmail.com
First Name & Middle Initial & Last Name & Degree
Euiju Lee, Ph.D.
First Name & Middle Initial & Last Name & Degree
Seungwon Shin, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23634356
Citation
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.
Results Reference
background
PubMed Identifier
1443950
Citation
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.
Results Reference
background
PubMed Identifier
25057270
Citation
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.
Results Reference
background
PubMed Identifier
19788912
Citation
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.
Results Reference
background
PubMed Identifier
27483466
Citation
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.
Results Reference
background
PubMed Identifier
25865680
Citation
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.
Results Reference
background
PubMed Identifier
22719787
Citation
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.
Results Reference
background
PubMed Identifier
27550184
Citation
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.
Results Reference
background
PubMed Identifier
24330810
Citation
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.
Results Reference
background
PubMed Identifier
2317323
Citation
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.
Results Reference
background
PubMed Identifier
21846956
Citation
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.
Results Reference
background
PubMed Identifier
1468055
Citation
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.
Results Reference
background
PubMed Identifier
22588750
Citation
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.
Results Reference
background
PubMed Identifier
20056385
Citation
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.
Results Reference
background
PubMed Identifier
16103297
Citation
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.
Results Reference
background
PubMed Identifier
27141228
Citation
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.
Results Reference
background
PubMed Identifier
15020033
Citation
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.
Results Reference
background
PubMed Identifier
29387128
Citation
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.
Results Reference
derived
Learn more about this trial
Herbal Medication (Gongjin-dan) for Chronic Dizziness
We'll reach out to this number within 24 hrs