Short-term Oral Prednisone for Acute Subjective Tinnitus
- Conditions
- Tinnitus, Subjective
- Interventions
- Registration Number
- NCT05591144
- Lead Sponsor
- Eye & ENT Hospital of Fudan University
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STOP group Prednisone tablet 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) STOP group Ginkgo Biloba Extract 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) placebol group Ginkgo Biloba Extract Patients took oral standardized Ginkgo biloba extracts (120 mg daily) three times a day.
- Primary Outcome Measures
Name Time Method tinnitus handicap inventory (THI) 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.
- Secondary Outcome Measures
Name Time Method visual analog scale (VAS) twelve weeks from baseline 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.
the Athens Insomnia Scale-8 (AIS-8) twelve weeks from baseline 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).
Trial Locations
- Locations (1)
Eye and ENT Hospital of Fudan University
🇨🇳Shanghai, China