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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
TJ0113 capsules
DrugOral 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 .
Placebo capsules
DrugOral 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 .
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: TJ0113 groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety of TJ0113 capsule in the treatment of patients with age-related hearing loss
Incidence of adverse events in each group
Time frame
Baseline, weeks 1, 4, 12, 24, and 1 week after discontinuationSecondary outcomes
1
Speech Intelligibility - Word Recognition in Quiet and Noise
To compare the change in word list-measured recognition accuracy rates for words and short sentences in both quiet and noise.
Time frame
From baseline to 4, 12 ,24 weeks2
Pure Tone Audiometry (PTA)
To ompare the change in Pure Tone Audiometry (PTA) using the air and bone conduction audiometry for hearing at certain range (Hz).
Time frame
From baseline to 4, 12 ,24 weeks3
Individual's health-related quality of life (HRQOL)
SF-36 quality of life questionnaire will be measured to compare the change in individual's health-related quality of life using face to face Interview for the scores. Higher scores mean better functioning or fewer symptoms.
Time frame
From baseline to 4, 12 ,24 weeksOther outcomes
1
Auditory brainstem response (ABR)
To compare the change in the auditory brainstem response (ABR) using the threshold (dB). Higher thresholds indicate worse outcomes.
Time frame
From baseline to 12 and 24 weeks2
Distortion product otoacoustic emissions (DPOAE)
To compare the changes in the pass rate levels of distortion product otoacoustic emissions（DPOAE).
Time frame
From baseline to 12 and 24 weeks3
Tinnitus Assessment
Tinnitus Handicap Inventory (THI) questionnaire scores will be measrued to compare the change in tinnitus using face to face Interview for the scores. Higher scores indicate worse outcomes.
Time frame
From baseline to 4, 12 and 24 weeks4
Muscle strength
To compare the change in the muscle strength (kg) measured with a handgrip dynamometer.
Time frame
From baseline to 4, 12 and 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yilai Shu
Lead sponsor
Eye & ENT Hospital of Fudan University
Sponsor institution
Hangzhou PhecdaMed Co., Ltd.
Collaborator
Source ClinicalTrials.gov
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