Different Dosing Regimens of STOP-AST

Eye & ENT Hospital of Fudan University

Status: Not yet enrolling

Conditions: Hearing Loss; Tinnitus; Sensorineural Hearing Loss

Treatments: Drug: Ginkgo Biloba Extract; Drug: Prednisone tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06124703

different STOP-AST regimens

Details and patient eligibility

About

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.

Full description

The purpose of this clinical study was to investigate the efficacy and to compare two different oral doses of short-term systemic steroid therapy for acute tinnitus.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-60 years old;

2. primary complaint of subjective tinnitus ≤ 1 months of duration;

3. 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:

   1. a reduced distortion product otoacoustic emissions (DPOAE) amplitude in individuals with normal Pure tone audiometry (PTA) results;
   2. more than a PTA threshold > 20 dB with frequencies between 125 and 8000 Hz, but not exhibited idiopathic sudden sensorineural hearing loss;

4. a state of good general condition;

5. with good adherence to participation and signed informed consent.

Exclusion criteria

1. active middle ear pathology;
2. patients who had received treatment for their current condition prior to the study;
3. both the PTA and DPOAE with normal outcomes;
4. hearing implants;
5. 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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162 participants in 2 patient groups

dose-tapering regimen

Active Comparator group

Description:

The dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days

Treatment:

Drug: Prednisone tablet

Drug: Ginkgo Biloba Extract

no taper regimen

Experimental group

Description:

The dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days

Treatment:

Drug: Prednisone tablet

Drug: Ginkgo Biloba Extract