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

Herbal Medication (Gongjin-dan) for Chronic Dizziness



Sponsors

Lead Sponsor



Source

Kyunghee University

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2018-04-01

Completion Date

2020-08-30

Primary Completion Date

2020-08-30

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Dizziness Handicap Inventory (DHI), change between baseline and endpoint
56 days

Secondary Outcome

Measure

Time Frame

Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42
14 days
Mean Vertigo Score (MVS), change between baseline and endpoint
56 days
Visual Analogue Scale (VAS), change between baseline and endpoint
56 days
Frequency of episodes (dizziness), change between baseline and endpoint
56 days
Berg Balance Scale (BBS), change between baseline and endpoint
56 days
Fatigue Severity Scale (FSS), change between baseline and endpoint
56 days
Global Perceived Effect (GPE)
Day 56
Korean version of Beck Depression Inventory (K-BDI), change between baseline and endpoint
56 days
State-Trait Anxiety Inventory (STAI), change between baseline and endpoint
56 days
Qi Blood Yin Yang deficiency questionnaire (QBYY-Q), change between baseline and endpoint
56 days
EuroQol five-dimensions questionnaire five-level (EQ-5D-5L), change between baseline and each assessment
Day 0, Day 56, Month 4, Month 8, Month 12
EuroQol five dimensions questionnaire visual analogue scale (EQ VAS), change between baseline and each assessment
Day 0, Day 56, Month 4, Month 8, Month 12

Enrollment

78

Condition


Intervention

Intervention Type

Drug

Intervention Name


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.

Arm Group Label

Gongjin-dan


Intervention Type

Drug

Intervention Name


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.

Arm Group Label

placebo



Eligibility

Criteria

Inclusion Criteria:

1. Age between 20 and 79 years, of either sex

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:

1. Dizziness attributable to vestibular disorders (e.g., benign paroxysmal positional
vertigo, peripheral vestibulopathy, labyrinthitis, vestibular neuronitis, and others)

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

Gender

All

Minimum Age

20 Years

Maximum Age

79 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Euiju Lee, Ph.D.
Principal Investigator
Kyunghee University

Overall Contact

Last Name

Euiju Lee, Ph.D.

Phone

+8229589230

Email

[email protected]


Location

Facility

Status

Contact

Semyung University Korean Medicine Hospital
Chungju Chungcheongbuk-do 27429 Korea, Republic of
Not yet recruiting
Last Name: Mi-Ran Shin, Ph.D.
Phone: +82 43-841-1734
Email: [email protected]
Dongguk University Ilsan Oriental Hospital
Goyang Gyeonggi-do 10326 Korea, Republic of
Not yet recruiting
Last Name: Seung-Ug Hong, Ph.D.
Phone: +82-31-961-9085
Email: [email protected]
Pusan National University Korean Medicine Hospital
Yangsan Gyeongsangnam-do 50612 Korea, Republic of
Not yet recruiting
Last Name: Hyung-Sik Seo, Ph.D.
Phone: +82 55-360-5630
Email: [email protected]
Kyung Hee University Korean Medicine Hospital
Seoul Special Seoul City 02447 Korea, Republic of
Not yet recruiting
Last Name: Eui-ju Lee, Ph.D.
Phone: +8229589230
Email: [email protected]
Last Name: Euiju Lee, Ph.D.
Role: Principal Investigator

Last Name: Seungwon Shin, M.D.
Role: Sub-Investigator


Location Countries

Country

Korea, Republic of


Verification Date

2017-07-01

Lastchanged Date

2017-07-13

Firstreceived Date

2017-07-10

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Kyunghee University

Investigator Full Name

Lee Eui-ju

Investigator Title

Professor, Ph.D. KMD.


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Gongjin-dan

Arm Group Type

Experimental

Description

Participants will be orally administered Gongjin-dan pills of 3.75g, 1 pill/day, 8 weeks (56 days).


Arm Group Label

placebo

Arm Group Type

Placebo Comparator

Description

Participants will be orally administered placebo pills of 3.75g, 1 pill/day, 8 weeks (56 days).



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Seungwon Shin, M.D.

Phone

+8229589730

Email

[email protected]


Reference

Citation

Kerber KA, Baloh RW. The evaluation of a patient with dizziness. Neurol Clin Pract. 2011 Dec;1(1):24-33.

PMID

23634356


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.

PMID

1443950


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.

PMID

25057270


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.

PMID

19788912


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.

PMID

27483466


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.

PMID

25865680


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.

PMID

22719787


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;17:418. doi: 10.1186/s13063-016-1542-7.

PMID

27550184


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.

PMID

24330810


Citation

Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7.

PMID

2317323


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.

PMID

21846956


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.

PMID

1468055


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. Review.

PMID

22588750


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.

PMID

20056385


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.

PMID

16103297


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.

PMID

27141228


Citation

Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56.

PMID

15020033



Acronym

GOODNESS

Other Outcome

Measure

Medical expenses on dizziness

Time Frame

Day 14, Day 28, Day 42, Day 56, Month 4, Month 8, Month 12

Description

medical and non-medical expenses to treat dizziness for estimating the incremental cost-effectiveness ratio


Measure

New Blinding index (New BI)

Time Frame

Day 56

Description

Blinding assessment



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Participant, Investigator, Outcomes Assessor



ClinicalTrials.gov processed this data on July 17, 2017

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Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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