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Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss

NCT05849519 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-05-09

No results posted yet for this study

Summary

Sudden sensorineural hearing loss is one of the most common emergencies in otorhinolaryngology, and its incidence is increasing year by year and tends to be younger. At present, the pathogenesis of sudden deafness is not clear and the individual treatment effects vary significantly. In order to break through this specific treatment bottleneck, this project pioneered the clinical application of the co-regulator nicotinamide adenine dinucleotide (NAD+) in the treatment of sudden deafness. Therefore, this project intends to use pure tone audiometry, speech audiometry, tinnitus disability scale THI, tinnitus subjective visual analog score method VAS, ear fullness subjective visual analog score method VAS for data analysis, and explore the safety of coenzyme I for injection on sudden deafness and efficacy assessment.

Conditions

  • Sudden Sensorineural Hearing Loss

Interventions

DRUG

Coenzyme I for Injection + conventional treatment

The intervention group used Coenzyme I for injection and conventional treatment for 7 consecutive days

DRUG

Conventional treatment

The control group was treated with conventional treatment

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2024-02-16
Completion
2024-02-16

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05849519 on ClinicalTrials.gov