Different Dosing Regimens of STOP-AST

E

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

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

Trial contacts and locations

0

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Central trial contact

Peifan Li; Shan Sun

Data sourced from clinicaltrials.gov

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