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

September 22, 2017 updated by: Lee Eui-ju, Kyunghee University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Chungcheongbuk-do
      • Chungju, Chungcheongbuk-do, Korea, Republic of, 27429
        • Semyung University Korean Medicine Hospital
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 10326
        • Dongguk University Ilsan Oriental Hospital
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
        • Pusan National University Korean Medicine Hospital
    • Special Seoul City
      • Seoul, Special Seoul City, Korea, Republic of, 02447
        • Kyung Hee University Korean Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dizziness Handicap Inventory (DHI), change between baseline and endpoint
Time Frame: 56 days
Assessment of the impairment caused by dizziness
56 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
14 days
Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56
Time Frame: 28 days
Assessment of the intensity of dizziness
28 days
Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56
Time Frame: 28 days
Assessment of the intensity of dizziness
28 days
Frequency of episodes (dizziness), changes between baseline and day 28 and day 56
Time Frame: 28 days
The frequency score of dizziness
28 days
Berg Balance Scale (BBS), changes between baseline and day 28 and day 56
Time Frame: 28 days
Assessment of the balance impairment
28 days
Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56
Time Frame: 28 days
Assessment of the severity of chronic fatigue
28 days
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
Day 56
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
28 days
State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56
Time Frame: 28 days
Assessment of the severity of anxiety
28 days
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
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
Assessment of the level of quality of life
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
Assessment of the level of quality of life
Day 0, Day 28, Day 56, Month 4, Month 8, Month 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Day 14, Day 28, Day 42, Day 56, Month 4, Month 8, Month 12
New Blinding index (New BI)
Time Frame: Day 56
Blinding assessment
Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyunghee University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HB16C0010-GJD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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