Tinnitus, SubjectiveSTOP-FASTNCT05591144
Short-term Oral Prednisone for Acute Subjective Tinnitus
A study testing Prednisone tablet and Ginkgo Biloba Extract in people with Tinnitus, Subjective, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to investigate the efficacy of oral steroids in the acute tinnitus population. Participants will receive appropriate dosages of short-term prednisone and/or oral Ginkgo Biloba tablets. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Prednisone tablet and Ginkgo Biloba Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2022to 3 Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old;
- a primary complaint of frequent occurrences of subjective tinnitus lasting at least 5 minutes within the past 3 months ;
- a definition of normal hearing in line with the World Report on Hearing (2021), of which the average value of hearing threshold at 500, 1000, 2000, 4000 Hz in better ear was less than 20 decibels;
- a score of more than 16 points on the Tinnitus Handicap Inventory (THI), which indicates that the level of tinnitus exceeds mild severity;
- a state of good general condition.
Who cannot join
- had previous history of middle ear pathology, apparent history of noise exposure, noise trauma or head injury;
- had received treatment for their current condition before the study;
- taken oral steroids within 3 months before randomization;
- had hearing implants;
- had participated in other clinical trials and have not terminated the trials;
- had a history of known corticosteroid contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnancy, or taking estrogen-containing oral contraceptive steroids);
- auditory hallucinations or other conditions deemed inappropriate for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus
The goal of this clinical trial is to investigate the efficacy of oral steroids in the acute tinnitus population. Participants will receive appropriate dosages of short-term prednisone and/or oral Ginkgo Biloba tablets.
Read the detailed description
Researchers will compare the intervention group and placebo-control group to see whether short-term systemic steroid therapy is effective for acute tinnitus.
- Conditions
- Tinnitus, Subjective
- Being tested
- Prednisone tablet, Ginkgo Biloba Extract
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone tabletDrug
Also called prednisone
The dose selection of oral prednisone is the maximum daily dose based on weight for 4 days, followed by a taper every 2 days, with the maximum duration to 14 days.
Ginkgo Biloba ExtractDrug
Also called ginkgo biloba
Ginkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus
| Study group | Role | What they receive |
|---|---|---|
| STOP group | Experimental | a 10mg/d tapering 14-day course of oral prednisone intervention (the initial dose: 1mg/kg/day, max 60mg/day) in combination with ginkgo biloba agent (120mg, three times/day) Receives: Drug: Prednisone tablet; Drug: Ginkgo Biloba Extract |
| placebol group | Placebo comparator | Patients took oral standardized Ginkgo biloba extracts (120 mg daily) three times a day. Receives: 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: 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: four 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: twelve weeks from baseline
Secondary outcomes (6)
visual analog scale (VAS)
The subjective perception of tinnitus loudness will be evaluated using a Visual Analog Scale (VAS). Participants will be instructed to rate the perceived loudness of their tinnitus on a scale ranging from 0, indicating "no loudness," to 10, representing "maximum imaginable loudness." Higher scores on this scale will correspond to greater perceived loudness of tinnitus symptoms.
Measured: two weeks from baseline
visual analog scale (VAS)
The subjective perception of tinnitus loudness will be evaluated using a Visual Analog Scale (VAS). Participants will be instructed to rate the perceived loudness of their tinnitus on a scale ranging from 0, indicating "no loudness," to 10, representing "maximum imaginable loudness." Higher scores on this scale will correspond to greater perceived loudness of tinnitus symptoms.
Measured: four weeks from baseline
visual analog scale (VAS)
The subjective perception of tinnitus loudness will be evaluated using a Visual Analog Scale (VAS). Participants will be instructed to rate the perceived loudness of their tinnitus on a scale ranging from 0, indicating "no loudness," to 10, representing "maximum imaginable loudness." Higher scores on this scale will correspond to greater perceived loudness of tinnitus symptoms.
Measured: twelve 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: 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: four 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: twelve weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start30 Oct 2022
- Primary completion22 Jan 2023
- Study completion3 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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
- 146 participants (actual)
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
- NCT05591144
- Sponsor's protocol ID
- STOP for AST
- Acronym
- STOP-FAST
- Status last verified
- May 2024
- First submitted
- 16 Oct 2022
- Last updated
- 28 Feb 2025
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT05591144
- Acronym / sponsor ID
- STOP-FAST / STOP for AST
- Conditions
- Tinnitus, Subjective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 22 Jan 2023 (actual)
- Study completion
- 3 Feb 2024 (actual)
- First posted
- 24 Oct 2022 (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 investigate the efficacy of oral steroids in the acute tinnitus population. Participants will receive appropriate dosages of short-term prednisone and/or oral Ginkgo Biloba tablets.
Detailed description
Researchers will compare the intervention group and placebo-control group to see whether short-term systemic steroid therapy is effective 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 |
|---|---|---|
| STOP group | Experimental | Drug: Prednisone tablet, Drug: Ginkgo Biloba Extracta 10mg/d tapering 14-day course of oral prednisone intervention (the initial dose: 1mg/kg/day, max 60mg/day) in combination with ginkgo biloba agent (120mg, three times/day) |
| placebol group | Placebo comparator | Drug: Ginkgo Biloba ExtractPatients took oral standardized Ginkgo biloba extracts (120 mg daily) three times a day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years old;
- a primary complaint of frequent occurrences of subjective tinnitus lasting at least 5 minutes within the past 3 months ;
- a definition of normal hearing in line with the World Report on Hearing (2021), of which the average value of hearing threshold at 500, 1000, 2000, 4000 Hz in better ear was less than 20 decibels;
- a score of more than 16 points on the Tinnitus Handicap Inventory (THI), which indicates that the level of tinnitus exceeds mild severity;
- a state of good general condition.
Key exclusion criteria (7 listed)
- had previous history of middle ear pathology, apparent history of noise exposure, noise trauma or head injury;
- had received treatment for their current condition before the study;
- taken oral steroids within 3 months before randomization;
- had hearing implants;
- had participated in other clinical trials and have not terminated the trials;
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: prednisoneThe dose selection of oral prednisone is the maximum daily dose based on weight for 4 days, followed by a taper every 2 days, with the maximum duration to 14 days. | Drug | STOP group |
| Ginkgo Biloba ExtractAlso: ginkgo bilobaGinkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus | Drug | STOP group, placebol group |
Primary outcome
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: four 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: twelve 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.
6 secondary outcomes
visual analog scale (VAS)
Time frame: two weeks from baseline
visual analog scale (VAS)
Time frame: four weeks from baseline
visual analog scale (VAS)
Time frame: twelve weeks from baseline
the Athens Insomnia Scale-8 (AIS-8)
Time frame: two weeks from baseline
the Athens Insomnia Scale-8 (AIS-8)
Time frame: four weeks from baseline
the Athens Insomnia Scale-8 (AIS-8)
Time frame: twelve weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone tablet and Ginkgo Biloba Extract in people with Tinnitus, Subjective, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 28 Feb 2025. 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 China. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: two weeks 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 28 Feb 2025.