Dizziness ChronicGOODNESSNCT03219515
Herbal Medication (Gongjin-dan) for Chronic Dizziness
A study testing Gongjin-Dan in people with Dizziness Chronic, run by Kyunghee University at 4 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Dizziness Chronic
- What is being tested?
- Gongjin-Dan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Apr 2018to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Semyung University Korean Medicine Hospital
Chungju, North Chungcheong, 27429
Mi-Ran Shin, Ph.D., +82 43-841-1734, shinmr19@hanmail.net
Dongguk University Ilsan Oriental Hospital
Goyang-si, Gyeonggi-do, 10326
Seung-Ug Hong, Ph.D., +82-31-961-9085, heenthsu@hanmail.net
Kyung Hee University Korean Medicine Hospital
Seoul, Special Seoul City, 02447
Eui-ju Lee, Ph.D., +8229589230, sasangin@daum.net
Seungwon Shin, M.D., +829589730, ssw.kmd@gmail.com
Pusan National University Korean Medicine Hospital
Yangsan, Gyeongsangnam-do, 50612
Hyung-Sik Seo, Ph.D., +82 55-360-5630, aran99@naver.com
About this study
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
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.
- Conditions
- Dizziness Chronic
- Being tested
- Gongjin-Dan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gongjin-DanDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Gongjin-dan | Experimental | Participants will be orally administered Gongjin-dan pills of 3.75g, 1 pill/day, 8 weeks (56 days). Receives: Drug: Gongjin-Dan |
| placebo | Placebo comparator | Participants will be orally administered placebo pills of 3.75g, 1 pill/day, 8 weeks (56 days). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory (DHI), change between baseline and endpoint
Assessment of the impairment caused by dizziness
Measured: 56 days
Secondary outcomes (12)
Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42
Assessment of the impairment caused by dizziness
Measured: 14 days
Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56
Assessment of the intensity of dizziness
Measured: 28 days
Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56
Assessment of the intensity of dizziness
Measured: 28 days
Frequency of episodes (dizziness), changes between baseline and day 28 and day 56
The frequency score of dizziness
Measured: 28 days
Berg Balance Scale (BBS), changes between baseline and day 28 and day 56
Assessment of the balance impairment
Measured: 28 days
Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56
Assessment of the severity of chronic fatigue
Measured: 28 days
Global Perceived Effect (GPE)
Assessment of a patient's perception of symptom worsening or improvement, Patient-rated outcome, 1 item, 1-7 scores
Measured: Day 56
Korean version of Beck Depression Inventory (K-BDI), changes between baseline and day 28 and day 56
Assessment of the severity of depression
Measured: 28 days
State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56
Assessment of the severity of anxiety
Measured: 28 days
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
Measured: 28 days
EuroQol five-dimensions questionnaire five-level (EQ-5D-5L), changes between baseline and each assessment
Assessment of the level of quality of life
Measured: Day 0, Day 28, Day 56, Month 4, Month 8, Month 12
EuroQol five dimensions questionnaire visual analogue scale (EQ VAS), change between baseline and each assessment
Assessment of the level of quality of life
Measured: Day 0, Day 28, Day 56, Month 4, Month 8, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start1 Apr 2018 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Dizziness ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Eui-ju, Kyunghee University
- Investigators
- Euiju Lee, Ph.D., Principal investigator, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219515
- Sponsor's protocol ID
- HB16C0010-GJD
- Acronym
- GOODNESS
- Status last verified
- Sep 2017
- First submitted
- 10 Jul 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23634356Kroenke 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.
PubMed 1443950Sokolova 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.
PubMed 25057270Moon 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.
PubMed 19788912Lee 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.
PubMed 27483466Hong 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.
PubMed 25865680Sunwoo 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.
PubMed 22719787Son 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.
PubMed 27550184Xue 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.
PubMed 24330810Jacobson 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.
PubMed 2317323Toupet 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.
PubMed 21846956Berg 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.
PubMed 1468055Hewlett 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.
PubMed 22588750Kamper 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.
PubMed 20056385Staab 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.
PubMed 16103297
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03219515
- Acronym / sponsor ID
- GOODNESS / HB16C0010-GJD
- Conditions
- Dizziness Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Kyunghee UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gongjin-dan | Experimental | Drug: Gongjin-DanParticipants will be orally administered Gongjin-dan pills of 3.75g, 1 pill/day, 8 weeks (56 days). |
| placebo | Placebo comparator | Drug: PlaceboParticipants will be orally administered placebo pills of 3.75g, 1 pill/day, 8 weeks (56 days). |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gongjin-DanGongjin-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. | Drug | Gongjin-dan |
| PlaceboPlacebo 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. | Drug | placebo |
Primary outcome
Dizziness Handicap Inventory (DHI), change between baseline and endpoint
Time frame: 56 days
Assessment of the impairment caused by dizziness
12 secondary outcomes
Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42
Time frame: 14 days
Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56
Time frame: 28 days
Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56
Time frame: 28 days
Frequency of episodes (dizziness), changes between baseline and day 28 and day 56
Time frame: 28 days
Berg Balance Scale (BBS), changes between baseline and day 28 and day 56
Time frame: 28 days
Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56
Time frame: 28 days
Global Perceived Effect (GPE)
Time frame: Day 56
Korean version of Beck Depression Inventory (K-BDI), changes between baseline and day 28 and day 56
Time frame: 28 days
State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56
Time frame: 28 days
Qi Blood Yin Yang deficiency questionnaire (QBYY-Q), changes between baseline and day 28 and day 56
Time frame: 28 days
EuroQol five-dimensions questionnaire five-level (EQ-5D-5L), changes between baseline and each assessment
Time frame: Day 0, Day 28, Day 56, Month 4, Month 8, Month 12
EuroQol five dimensions questionnaire visual analogue scale (EQ VAS), change between baseline and each assessment
Time frame: Day 0, Day 28, Day 56, Month 4, Month 8, Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Background: PubMed 23634356Kerber KA, Baloh RW. The evaluation of a patient with dizziness. Neurol Clin Pract. 2011 Dec;1(1):24-33. doi: 10.1212/CPJ.0b013e31823d07b6.
- Background: PubMed 1443950Kroenke 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.
- Background: PubMed 25057270Sokolova 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.
- Background: PubMed 19788912Moon 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.
- Background: PubMed 27483466Lee 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.
- Background: PubMed 25865680Hong 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.
- Background: PubMed 22719787Sunwoo 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.
- Background: PubMed 27550184Son 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.
- Background: PubMed 24330810Xue 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.
- Background: PubMed 2317323Jacobson 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.
- Background: PubMed 21846956Toupet 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.
- Background: PubMed 1468055Berg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Euiju Lee, Ph.D. principal investigator
Kyunghee University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gongjin-Dan in people with Dizziness Chronic, run by Kyunghee University at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Euiju Lee, Ph.D. (+8229589230, sasangin@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory (DHI), change between baseline and endpoint (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219515, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.