Short-term Oral Prednisone for Acute Subjective Tinnitus

NCT ID: NCT05591144

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-30
• Study Completion Date: 2024-02-03

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.

Conditions

Tinnitus, Subjective

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Prednisone tablet

Intervention Type: 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.

Ginkgo Biloba Extract

Intervention Type: DRUG

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

placebol group

Patients took oral standardized Ginkgo biloba extracts (120 mg daily) three times a day.

Group Type: PLACEBO_COMPARATOR

Ginkgo Biloba Extract

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

prednisone; ginkgo biloba

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shan Sun

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Locations

Eye and ENT Hospital of Fudan University

Shanghai, , China

Countries

China

Other Identifiers

STOP for AST

Identifier Type: -

Identifier Source: org_study_id