NCT01663467

Brief Summary

The purpose of this study is to prove the efficacy of the internet and smartphone application-delivered tinnitus retraining therapy (TRT).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

August 8, 2012

Last Update Submit

October 23, 2016

Conditions

Tinnitus

Keywords

tinnitussmartphoneWeb

Outcome Measures

Primary Outcomes (1)

  • Tinnitus Handicap Inventory (THI)

    THI will be evaluated 6 months after TRT using smatrphone and web

    6 months

Study Arms (2)

Ginkgo biloba only

ACTIVE COMPARATOR

control group Ginexin-F 80mg tablet will be given twice a day for 6 months.

Drug: Ginkgo biloba

Ginkgo biloba + modified TRT

EXPERIMENTAL

experimental group modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba. Ginexin-F 80mg tablet will be given twice a day for 6 months.

Drug: Ginkgo bilobaBehavioral: modified TRT

Interventions

Ginkgo bilobaDRUG

Ginexin-F 80mg tablet will be given twice a day for 6 months.

Also known as: Ginexin-F
Ginkgo biloba + modified TRTGinkgo biloba only
modified TRTBEHAVIORAL

modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba. Ginexin-F 80mg tablet will be given twice a day for 6 months.

Ginkgo biloba + modified TRT

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic subjective tinnitus

You may not qualify if:

  • THI \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Ginkgo Extract

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • YOUNG HO KIM, MD., PhD

    Seoul National University Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Otolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul National University Boramae Medical Center

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 13, 2012

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)