Different Dosing Regimens of STOP-AST
Comparing Two Dosing Regimens of the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus
1 other identifier
interventional
162
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2023
CompletedFirst Posted
Study publicly available on registry
November 9, 2023
CompletedStudy Start
First participant enrolled
November 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedNovember 13, 2023
November 1, 2023
3 months
November 5, 2023
November 8, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
one month from baseline
Secondary Outcomes (6)
visual analog scale (VAS)
one week from baseline
visual analog scale (VAS)
two weeks from baseline
visual analog scale (VAS)
one month from baseline
the Athens Insomnia Scale-8 (AIS-8)
one week from baseline
the Athens Insomnia Scale-8 (AIS-8)
two weeks from baseline
- +1 more secondary outcomes
Study Arms (2)
dose-tapering regimen
ACTIVE COMPARATORThe dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days
no taper regimen
EXPERIMENTALThe dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days
Interventions
Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided
Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shan Sun
Eye and ENT Hospital of Fudan University
Central Study Contacts
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
- SPONSOR
Study Record Dates
First Submitted
November 5, 2023
First Posted
November 9, 2023
Study Start
November 10, 2023
Primary Completion
February 10, 2024
Study Completion
November 30, 2024
Last Updated
November 13, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share