Short-term Oral Prednisone for Acute Subjective Tinnitus

NCT05591144 | Completed

• 1 other identifier: STOP for AST
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus, Subjective

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.

  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.

  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.

  twelve weeks from baseline

Secondary Outcomes (6)

• visual analog scale (VAS)

  two weeks from baseline

• visual analog scale (VAS)

  four weeks from baseline

• visual analog scale (VAS)

  twelve weeks from baseline

• the Athens Insomnia Scale-8 (AIS-8)

  two weeks from baseline

• the Athens Insomnia Scale-8 (AIS-8)

  four weeks from baseline

Study Arms (2)

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)

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.

Drug: Ginkgo Biloba Extract

Interventions

Prednisone tablet DRUG

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.

Also known as: prednisone

STOP group

Ginkgo Biloba Extract DRUG

Ginkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus

Also known as: ginkgo biloba

STOP group; placebol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye and ENT Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Prednisone; Ginkgo biloba extract; Ginkgo Extract

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Shan Sun

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

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: October 16, 2022
• First Posted: October 24, 2022
• Study Start: October 30, 2022
• Primary Completion: January 22, 2023
• Study Completion: February 3, 2024
• Last Updated: February 28, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)