A Clinical Trial of the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-75
SponsorYilai Shu
About this trial
The purpose of this study is to explore the safety and efficacy of TJ0113 capsules in patients with age-related hearing loss.
Eligibility criteria
Qualifiers
The subjects voluntarily participate in the clinical trial, sign the informed consent form, understand and follow the protocol, and fully understand the test content, process and possible adverse reactions.
Age between 65 and 80 years (including the critical value)
A diagnosis of symmetrical sensorineural deafness (SNHL) with a history of> 3 months (binaural threshold difference in mean PTA frequency <15 dB HL), the PTA level should be between moderate (> 35dB) and severe (<80dB) hearing loss
Hearing aids have not been used, or otherwise, it should be used regularly for more than 3 years and stopped for 3 months before enrollment.
Disqualifiers
The presence of implants in the study ear (such as cochlear implant, artificial hearing bone, etc.);
Suffering from acute otitis media or other ear infection within the previous 3 months or previous chronic suppurative otitis media or tympanic membrane perforation, or with conductive deafness, previous history of ear trauma or surgery, combined middle ear or inner ear malformation, otosclerosis, Meniere's disease, sudden deafness and no recovery of hearing, all of which will impact results explained.
Patients with sensorineural deafness caused by non-aging factors (e. g., hereditary deafness, congenital deafness, drug-induced deafness, noise deafness, neurosyphilis, severe retrocochlear lesions or organic lesions), and unilateral deafness
Occupation that is sensitive to sound: musician, conductor, music teacher, etc.
Trial design
Treatments tested in this trial
- TJ0113 capsules
- Placebo capsules
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yilai Shu
Lead sponsor
Eye & ENT Hospital of Fudan University
Sponsor institution
Hangzhou PhecdaMed Co., Ltd.
Collaborator
Source ClinicalTrials.gov