NCT07012746

A Clinical Trial of the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss

A Randomized, Double-Blind, Placebo-Parallel-Controlled Clinical Trial to Explore the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yilai Shu · Academic / Other
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the safety and efficacy of TJ0113 capsules in patients with age-related hearing loss.

Detailed description

The main purpose of this clinical trial is to explore the safety of TJ0113 capsules in patients with age-related hearing loss; the secondary purpose is to explore the effectiveness; and the exploratory purpose is to exploring changes in muscle strength, depression degree, cognition, and biomarkers after TJ0113 capsule treatment in patients with age-related hearing loss. Approximately 60 subjects (aged from 65\~75) will be enrolled in this study according to the randomization and drug randomization tables both of which were generated by computer. The successfully screened subjects were randomly assigned to the 1:1 TJ0113 capsule group (n=30) and placebo group (n=30).

Conditions

• Age Related Hearing Loss
• Deafness

Interventions

Type	Name	Description
DRUG	TJ0113 capsules	Oral intake on an empty stomach in the morning, 200 mg each time, fasting within half an hour after taking. It is recommended to keep the drug at the same time (± 1 h ) of a day .
DRUG	Placebo capsules	Oral intake on an empty stomach in the morning, 200 mg each time, fasting within half an hour after taking. It is recommended to keep the drug at the same time (± 1 h ) of a day .

Timeline

• Start date: 2025-06-07
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: China