Herbal Medication (Gongjin-dan) for Chronic Dizziness

NCT03219515 | Unknown

• 1 other identifier: HB16C0010-GJD
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 4

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.

Conditions

Dizziness Chronic

Outcome Measures

Primary Outcomes (1)

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

  Assessment of the impairment caused by dizziness

  56 days

Secondary Outcomes (12)

• Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42

  14 days

• Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56

  28 days

• Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56

  28 days

• Frequency of episodes (dizziness), changes between baseline and day 28 and day 56

  28 days

• Berg Balance Scale (BBS), changes between baseline and day 28 and day 56

  28 days

Other Outcomes (2)

• Medical expenses on dizziness

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

• New Blinding index (New BI)

  Day 56

Study Arms (2)

Gongjin-dan

EXPERIMENTAL

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

Drug: Gongjin-Dan

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Gongjin-Dan DRUG

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.

Gongjin-dan

Placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University: lead

Study Sites (4)

Dongguk University Ilsan Oriental Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Location

Pusan National University Korean Medicine Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Semyung University Korean Medicine Hospital

Chungju, North Chungcheong, 27429, South Korea

Location

Kyung Hee University Korean Medicine Hospital

Seoul, Special Seoul City, 02447, South Korea

Location

Related Publications (18)

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  PMID: 23634356 BACKGROUND

• 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.

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• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 2317323 BACKGROUND

• 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.

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• 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.

  PMID: 29387128 DERIVED

MeSH Terms

Interventions

Gongjin-dan

Study Officials

• Euiju Lee, Ph.D.

  Kyunghee University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Euiju Lee, Ph.D.

CONTACT

+8229589230; sasangin@daum.net

Seungwon Shin, M.D.

CONTACT

+8229589730; ssw.kmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ph.D. KMD.

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 17, 2017
• Study Start: April 1, 2018
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)