Hearing LossNCT06124703
Different Dosing Regimens of STOP-AST
A study testing Prednisone tablet and Ginkgo Biloba Extract in people with Hearing Loss and Tinnitus, run by Eye & ENT Hospital of Fudan University.
Trial summary
The goal of this clinical trial is to learn about the different dose regimens of the efficacy of oral steroids in the acute tinnitus population. Participants will receive different appropriate dosages of prednisone tablets and oral Ginkgo Biloba tablets. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hearing Loss, Tinnitus, Sensorineural Hearing Loss
- What is being tested?
- Prednisone tablet and Ginkgo Biloba Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2023to 30 Nov 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old;
- primary complaint of subjective tinnitus ≤ 1 months of duration;
- a decline in auditory function by audiological assessments on the day of the test, of which the outcome must either satisfy one of the following conditions:
- a reduced distortion product otoacoustic emissions (DPOAE) amplitude in individuals with normal Pure tone audiometry (PTA) results;
- more than a PTA threshold > 20 dB with frequencies between 125 and 8000 Hz, but not exhibited idiopathic sudden sensorineural hearing loss;
- a state of good general condition;
- with good adherence to participation and signed informed consent.
Who cannot join
- active middle ear pathology;
- patients who had received treatment for their current condition prior to the study;
- both the PTA and DPOAE with normal outcomes;
- hearing implants;
- history of known corticosteroids contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnant patients, and women on estrogen-containing oral contraceptive steroids).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparing Two Dosing Regimens of the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus
The goal of this clinical trial is to learn about the different dose regimens of the efficacy of oral steroids in the acute tinnitus population. Participants will receive different appropriate dosages of prednisone tablets and oral Ginkgo Biloba tablets.
Read the detailed description
The purpose of this clinical study was to investigate the efficacy and to compare two different oral doses of short-term systemic steroid therapy for acute tinnitus.
- Conditions
- Hearing Loss, Tinnitus, Sensorineural Hearing Loss
- Being tested
- Prednisone tablet, Ginkgo Biloba Extract
- Medical subject headings
- Hearing Loss, Tinnitus, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone tabletDrug
Also called Prednisone
Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided
Ginkgo Biloba ExtractDrug
Also called EGb
Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.
| Study group | Role | What they receive |
|---|---|---|
| dose-tapering regimen | Active comparator | The dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days Receives: Drug: Prednisone tablet; Drug: Ginkgo Biloba Extract |
| no taper regimen | Experimental | The dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days Receives: Drug: Prednisone tablet; Drug: Ginkgo Biloba Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
tinnitus handicap inventory (THI)
The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus
Measured: one week from baseline
tinnitus handicap inventory (THI)
The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus
Measured: two weeks from baseline
tinnitus handicap inventory (THI)
The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus
Measured: one month from baseline
Secondary outcomes (6)
visual analog scale (VAS)
mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
Measured: one week from baseline
visual analog scale (VAS)
mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
Measured: two weeks from baseline
visual analog scale (VAS)
mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
Measured: one month from baseline
the Athens Insomnia Scale-8 (AIS-8)
The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).
Measured: one week from baseline
the Athens Insomnia Scale-8 (AIS-8)
The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).
Measured: two weeks from baseline
the Athens Insomnia Scale-8 (AIS-8)
The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).
Measured: one month from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start10 Nov 2023 (estimated)
- Primary completion10 Feb 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shan Sun, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124703
- Sponsor's protocol ID
- different STOP-AST regimens
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Dosing Regimens of the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT06124703
- Acronym / sponsor ID
- different STOP-AST regimens
- Conditions
- Hearing Loss, Tinnitus, Sensorineural Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (estimated)
- Primary completion
- 10 Feb 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 9 Nov 2023 (actual)
- 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 goal of this clinical trial is to learn about the different dose regimens of the efficacy of oral steroids in the acute tinnitus population. Participants will receive different appropriate dosages of prednisone tablets and oral Ginkgo Biloba tablets.
Detailed description
The purpose of this clinical study was to investigate the efficacy and to compare two different oral doses of short-term systemic steroid therapy for acute tinnitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dose-tapering regimen | Active comparator | Drug: Prednisone tablet, Drug: Ginkgo Biloba ExtractThe dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days |
| no taper regimen | Experimental | Drug: Prednisone tablet, Drug: Ginkgo Biloba ExtractThe dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-60 years old;
- primary complaint of subjective tinnitus ≤ 1 months of duration;
- a decline in auditory function by audiological assessments on the day of the test, of which the outcome must either satisfy one of the following conditions:
- a state of good general condition;
- with good adherence to participation and signed informed consent.
Key exclusion criteria (5 listed)
- active middle ear pathology;
- patients who had received treatment for their current condition prior to the study;
- both the PTA and DPOAE with normal outcomes;
- hearing implants;
- history of known corticosteroids contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnant patients, and women on estrogen-containing oral contraceptive steroids).
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 |
|---|---|---|
| Prednisone tabletAlso: PrednisonePrednisone acetate tablet (5 mg prednisone acetate per tablet) was provided | Drug | dose-tapering regimen, no taper regimen |
| Ginkgo Biloba ExtractAlso: EGbGinkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China. | Drug | dose-tapering regimen, no taper regimen |
Primary outcome
tinnitus handicap inventory (THI)
Time frame: one week from baseline
The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus
tinnitus handicap inventory (THI)
Time frame: two weeks from baseline
The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus
tinnitus handicap inventory (THI)
Time frame: one month from baseline
The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus
6 secondary outcomes
visual analog scale (VAS)
Time frame: one week from baseline
visual analog scale (VAS)
Time frame: two weeks from baseline
visual analog scale (VAS)
Time frame: one month from baseline
the Athens Insomnia Scale-8 (AIS-8)
Time frame: one week from baseline
the Athens Insomnia Scale-8 (AIS-8)
Time frame: two weeks from baseline
the Athens Insomnia Scale-8 (AIS-8)
Time frame: one month from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- 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.
Shan Sun principal investigator
Eye & ENT Hospital of Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone tablet and Ginkgo Biloba Extract in people with Hearing Loss and Tinnitus, run by Eye & ENT Hospital of Fudan University.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shan Sun (+86-18917786102, sunshine7896@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tinnitus handicap inventory (THI) (time frame: one week from baseline). The study lists 3 primary outcomes in all. 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 13 Nov 2023.