TinnitusNCT01663467
Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy
A study testing Ginkgo biloba and modified TRT in people with Tinnitus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to prove the efficacy of the internet and smartphone application-delivered tinnitus retraining therapy (TRT). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Ginkgo biloba and modified TRT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic subjective tinnitus
Who cannot join
- THI < 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Internet and Smartphone Application-delivered TRT
The purpose of this study is to prove the efficacy of the internet and smartphone application-delivered tinnitus retraining therapy (TRT).
Read the detailed description
to investigate the effect of TRT with minimized counseling
- Conditions
- Tinnitus
- Being tested
- Ginkgo biloba, modified TRT
- Keywords
- tinnitus, smartphone, Web
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo bilobaDrug
Also called Ginexin-F
Ginexin-F 80mg tablet will be given twice a day for 6 months.
modified TRTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Ginkgo biloba only | Active comparator | control group Ginexin-F 80mg tablet will be given twice a day for 6 months. Receives: 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. Receives: Drug: Ginkgo biloba; Behavioral: modified TRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory (THI)
THI will be evaluated 6 months after TRT using smatrphone and web
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: there was no participants who were enrolled in this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Soonchunhyang University Hospital
- Responsible party
- Principal investigator, YOUNG HO KIM, Seoul National University Hospital
- Investigators
- YOUNG HO KIM, MD., PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663467
- Sponsor's protocol ID
- SNUH_YHK_TRT
- Status last verified
- Oct 2016
- First submitted
- 8 Aug 2012
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Internet and Smartphone Application-delivered TRT
- ClinicalTrials.gov ID
- NCT01663467
- Acronym / sponsor ID
- SNUH_YHK_TRT
- Conditions
- Tinnitus
- Keywords
- tinnitus, smartphone, Web
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: there was no participants who were enrolled in this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Soonchunhyang University Hospital
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prove the efficacy of the internet and smartphone application-delivered tinnitus retraining therapy (TRT).
Detailed description
to investigate the effect of TRT with minimized counseling
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginkgo biloba only | Active comparator | Drug: Ginkgo bilobacontrol group Ginexin-F 80mg tablet will be given twice a day for 6 months. |
| Ginkgo biloba + modified TRT | Experimental | Drug: Ginkgo biloba, Behavioral: modified TRTexperimental 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic subjective tinnitus
Key exclusion criteria (1 listed)
- THI < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginkgo bilobaAlso: Ginexin-FGinexin-F 80mg tablet will be given twice a day for 6 months. | Drug | Ginkgo biloba + modified TRT, Ginkgo biloba only |
| modified TRTmodified 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. | Behavioural | Ginkgo biloba + modified TRT |
Primary outcome
Tinnitus Handicap Inventory (THI)
Time frame: 6 months
THI will be evaluated 6 months after TRT using smatrphone and web
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YOUNG HO KIM, MD., PhD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginkgo biloba and modified TRT in people with Tinnitus, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (THI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.