Different Dosing Regimens of STOP-AST

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hearing Loss Tinnitus Sensorineural Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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dose-tapering regimen

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

Group Type ACTIVE_COMPARATOR

Prednisone tablet

Intervention Type DRUG

Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided

Ginkgo Biloba Extract

Intervention Type DRUG

Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.

no taper regimen

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

Group Type EXPERIMENTAL

Prednisone tablet

Intervention Type DRUG

Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided

Ginkgo Biloba Extract

Intervention Type DRUG

Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.

Interventions

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Prednisone tablet

Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided

Intervention Type DRUG

Ginkgo Biloba Extract

Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.

Intervention Type DRUG

Other Intervention Names

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Prednisone EGb

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No