Herbal Medication (Gongjin-dan) for Chronic Dizziness

Dizziness Chronic Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03219515
• Other study ID #: HB16C0010-GJD
• Status: Not yet recruiting
• Phase: N/A
• First received: July 10, 2017
• Last updated: September 22, 2017
• Start date: April 1, 2018
• Est. completion date: August 30, 2020

Study information

• Verified date: September 2017
• Source: Kyunghee University
• Contact: Euiju Lee, Ph.D.
• Phone: +8229589230
• Email: sasangin[@]daum.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Dizziness Chronic
• Vertigo

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Semyung University Korean Medicine Hospital	Chungju	Chungcheongbuk-do
Korea, Republic of	Dongguk University Ilsan Oriental Hospital	Goyang	Gyeonggi-do
Korea, Republic of	Kyung Hee University Korean Medicine Hospital	Seoul	Special Seoul City
Korea, Republic of	Pusan National University Korean Medicine Hospital	Yangsan	Gyeongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (17)

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

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

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

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medical expenses on dizziness	medical and non-medical expenses to treat dizziness for estimating the incremental cost-effectiveness ratio	Day 14, Day 28, Day 42, Day 56, Month 4, Month 8, Month 12
Other	New Blinding index (New BI)	Blinding assessment	Day 56
Primary	Dizziness Handicap Inventory (DHI), change between baseline and endpoint	Assessment of the impairment caused by dizziness	56 days
Secondary	Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42	Assessment of the impairment caused by dizziness	14 days
Secondary	Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56	Assessment of the intensity of dizziness	28 days
Secondary	Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56	Assessment of the intensity of dizziness	28 days
Secondary	Frequency of episodes (dizziness), changes between baseline and day 28 and day 56	The frequency score of dizziness	28 days
Secondary	Berg Balance Scale (BBS), changes between baseline and day 28 and day 56	Assessment of the balance impairment	28 days
Secondary	Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56	Assessment of the severity of chronic fatigue	28 days
Secondary	Global Perceived Effect (GPE)	Assessment of a patient's perception of symptom worsening or improvement, Patient-rated outcome, 1 item, 1-7 scores	Day 56
Secondary	Korean version of Beck Depression Inventory (K-BDI), changes between baseline and day 28 and day 56	Assessment of the severity of depression	28 days
Secondary	State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56	Assessment of the severity of anxiety	28 days
Secondary	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	28 days
Secondary	EuroQol five-dimensions questionnaire five-level (EQ-5D-5L), changes between baseline and each assessment	Assessment of the level of quality of life	Day 0, Day 28, Day 56, Month 4, Month 8, Month 12
Secondary	EuroQol five dimensions questionnaire visual analogue scale (EQ VAS), change between baseline and each assessment	Assessment of the level of quality of life	Day 0, Day 28, Day 56, Month 4, Month 8, Month 12