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Herbal Medication (Gongjin-dan) for Chronic Dizziness

NCT03219515 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2017-09-25

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Kyunghee University

    lead OTHER

Principal Investigators

  • Euiju Lee, Ph.D. · Kyunghee University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2020-08-30
Completion
2020-08-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03219515 on ClinicalTrials.gov