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Herbal Medication (Gongjin-dan) for Chronic Dizziness (GOODNESS)

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ClinicalTrials.gov Identifier: NCT03219515
Recruitment Status : Not yet recruiting
First Posted : July 17, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Lee Eui-ju, Kyunghee University

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.

Condition or disease Intervention/treatment Phase
Dizziness Chronic Drug: Gongjin-Dan Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gongjin-dan
Participants will be orally administered Gongjin-dan pills of 3.75g, 1 pill/day, 8 weeks (56 days).
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 Comparator: placebo
Participants will be orally administered placebo pills of 3.75g, 1 pill/day, 8 weeks (56 days).
Drug: 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.




Primary Outcome Measures :
  1. Dizziness Handicap Inventory (DHI), change between baseline and endpoint [ Time Frame: 56 days ]
    Assessment of the impairment caused by dizziness


Secondary Outcome Measures :
  1. Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42 [ Time Frame: 14 days ]
    Assessment of the impairment caused by dizziness

  2. Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56 [ Time Frame: 28 days ]
    Assessment of the intensity of dizziness

  3. Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56 [ Time Frame: 28 days ]
    Assessment of the intensity of dizziness

  4. Frequency of episodes (dizziness), changes between baseline and day 28 and day 56 [ Time Frame: 28 days ]
    The frequency score of dizziness

  5. Berg Balance Scale (BBS), changes between baseline and day 28 and day 56 [ Time Frame: 28 days ]
    Assessment of the balance impairment

  6. Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56 [ Time Frame: 28 days ]
    Assessment of the severity of chronic fatigue

  7. Global Perceived Effect (GPE) [ Time Frame: Day 56 ]
    Assessment of a patient's perception of symptom worsening or improvement, Patient-rated outcome, 1 item, 1-7 scores

  8. Korean version of Beck Depression Inventory (K-BDI), changes between baseline and day 28 and day 56 [ Time Frame: 28 days ]
    Assessment of the severity of depression

  9. State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56 [ Time Frame: 28 days ]
    Assessment of the severity of anxiety

  10. Qi Blood Yin Yang deficiency questionnaire (QBYY-Q), changes between baseline and day 28 and day 56 [ Time Frame: 28 days ]
    Assessment of the level of deficiency pattern/syndrome in traditional Korean medicine

  11. 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 ]
    Assessment of the level of quality of life

  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 ]
    Assessment of the level of quality of life


Other Outcome Measures:
  1. Medical expenses on dizziness [ Time Frame: Day 14, Day 28, Day 42, Day 56, Month 4, Month 8, Month 12 ]
    medical and non-medical expenses to treat dizziness for estimating the incremental cost-effectiveness ratio

  2. New Blinding index (New BI) [ Time Frame: Day 56 ]
    Blinding assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219515


Contacts
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Contact: Euiju Lee, Ph.D. +8229589230 sasangin@daum.net
Contact: Seungwon Shin, M.D. +8229589730 ssw.kmd@gmail.com

Locations
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Korea, Republic of
Semyung University Korean Medicine Hospital Not yet recruiting
Chungju, Chungcheongbuk-do, Korea, Republic of, 27429
Contact: Mi-Ran Shin, Ph.D.    +82 43-841-1734    shinmr19@hanmail.net   
Dongguk University Ilsan Oriental Hospital Not yet recruiting
Goyang, Gyeonggi-do, Korea, Republic of, 10326
Contact: Seung-Ug Hong, Ph.D.    +82-31-961-9085    heenthsu@hanmail.net   
Pusan National University Korean Medicine Hospital Not yet recruiting
Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
Contact: Hyung-Sik Seo, Ph.D.    +82 55-360-5630    aran99@naver.com   
Kyung Hee University Korean Medicine Hospital Not yet recruiting
Seoul, Special Seoul City, Korea, Republic of, 02447
Contact: Eui-ju Lee, Ph.D.    +8229589230    sasangin@daum.net   
Contact: Seungwon Shin, M.D.    +829589730    ssw.kmd@gmail.com   
Principal Investigator: Euiju Lee, Ph.D.         
Sub-Investigator: Seungwon Shin, M.D.         
Sponsors and Collaborators
Kyunghee University
Investigators
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Principal Investigator: Euiju Lee, Ph.D. Kyunghee University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lee Eui-ju, Professor, Ph.D. KMD., Kyunghee University
ClinicalTrials.gov Identifier: NCT03219515     History of Changes
Other Study ID Numbers: HB16C0010-GJD
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vertigo
Dizziness
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases