Short-term Oral Prednisone for Acute Subjective Tinnitus (STOP-FAST)

February 26, 2025 updated by: Eye & ENT Hospital of Fudan University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Eye and ENT Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18-65 years old;
  2. a primary complaint of frequent occurrences of subjective tinnitus lasting at least 5 minutes within the past 3 months ;
  3. 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;
  4. a score of more than 16 points on the Tinnitus Handicap Inventory (THI), which indicates that the level of tinnitus exceeds mild severity;
  5. a state of good general condition.

Exclusion Criteria:

  1. had previous history of middle ear pathology, apparent history of noise exposure, noise trauma or head injury;
  2. had received treatment for their current condition before the study;
  3. taken oral steroids within 3 months before randomization;
  4. had hearing implants;
  5. had participated in other clinical trials and have not terminated the trials;
  6. 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);
  7. auditory hallucinations or other conditions deemed inappropriate for inclusion by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STOP group
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)
Drug: Ginkgo Biloba Extract
Ginkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus
Other Names:
  • ginkgo biloba
Drug: Prednisone tablet
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.
Other Names:
  • prednisone
Placebo Comparator: placebol group
Patients took oral standardized Ginkgo biloba extracts (120 mg daily) three times a day.
Drug: Ginkgo Biloba Extract
Ginkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus
Other Names:
  • ginkgo biloba

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
two weeks from baseline
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.
four weeks from baseline
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.
twelve weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Athens Insomnia Scale-8 (AIS-8)
Time Frame: two 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).
two weeks from baseline
the Athens Insomnia Scale-8 (AIS-8)
Time Frame: four 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).
four weeks from baseline
the Athens Insomnia Scale-8 (AIS-8)
Time Frame: 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).
twelve weeks from baseline
visual analog scale (VAS)
Time Frame: two 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.
two weeks from baseline
visual analog scale (VAS)
Time Frame: four 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.
four weeks from baseline
visual analog scale (VAS)
Time Frame: 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.
twelve weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Investigators

  • Principal Investigator: Shan Sun, Eye and ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2022

Primary Completion (Actual)

January 22, 2023

Study Completion (Actual)

February 3, 2024

Study Registration Dates

First Submitted

October 16, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOP for AST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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