NCT05849519

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The recruited participants were patients with sudden hearing deafness, and the basic demographic data, including name, gender, age, medical history, etc., were collected. According to the inclusion and exclusion criteria, the patients were randomly divided into the experimental group and the control group. The experimental group was given conventional treatment + coenzyme I for injection, and the control group was given conventional treatment for 14 days. Baseline data were collected before treatment, and post-treatment data were collected on 3d, 7d, 14d，1m and 3m of treatment. Baseline data and post-treatment data included pure tone audiometry, speech audiometry, tinnitus THI scale, tinnitus VAS scale, tinnitus Stupid VAS scale.

Conditions

• Sudden Sensorineural Hearing Loss

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-16
• Primary completion: 2024-02-16
• Completion: 2024-02-16
• First posted: 2023-05-09
• Last updated: 2023-05-09

Locations

1 site across 1 country: China