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Not yet recruitingNCT07012746Updated Jun 10, 2025

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

An interventional study of TJ0113 capsules and Placebo capsules in Age Related Hearing Loss and Deafness, sponsored by Yilai Shu. Not yet recruiting at 1 site in China. Open to participants aged 65 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by Yilai Shu · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Age Related Hearing Loss
  • Deafness
03

In context

Presbycusis

66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 45 interventional studies indexed under Presbycusis.

Browse Presbycusis studies →

Lead sponsor

Yilai Shu is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The subjects voluntarily participate in the clinical trial, sign the form, understand and follow the protocol, and fully understand the test content, process and possible adverse reactions.
  2. Age between 65 and 80 years (including the critical value)
  3. 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
  4. 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.
  5. Subjects and their partners had no birth plan, sperm or egg donation plans from the screening period until within 6 months after the end of the trial and would voluntarily take effective (e. g. abstinence, condoms, etc.). Male subjects should agree to avoid sperm donation within 6 months from the start of administration until cessation of study treatment. Female subjects should be menopausal (over 24 months).

Exclusion criteria

Exclusion Criteria:

  1. The presence of implants in the study ear (such as cochlear implant, artificial hearing bone, etc.);
  2. 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.
  3. 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
  4. Occupation that is sensitive to sound: musician, conductor, music teacher, etc.
  5. Use headphones at high volume or frequent exposure to noise in previous work or life;
  6. History of alcohol or drug dependence / drug abuse in the last 1 year;
  7. Positive pregnancy test at screening or at the baseline visit, pregnant, lactating, or planned to become pregnant during the trial

7.Failure to swallow oral medication, or, according to the investigator, any conditions that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or that may pose a hazard to the subjects participating in this trial; 9.People who currently taking drugs that can improve symptoms such as dementia and depression 10.Subjects with a severe or unstable systemic disease, such as serious congenital disease, blood disease, endocrine disease, nerve or nervous system disease, end-stage disease, head and neck tumor radiotherapy and chemotherapy history, major surgical treatment, psychological disorders (severe insomnia, severe depression, severe anxiety, etc. diagnosed within the previous 90 days ) or history and clinical significance of abnormal baseline laboratory values, such as hepatic insufficiency ( (ALT) and / or alanine transaminase (AST) is 2 times above the upper limit of the reference range, or renal insufficiency ( Ccr \<30 mL/min), or history of malignant tumors and the detection results of tumor markers during the screening period have clinical significance, or unsuitable participants, as judged by the investigator; 11.Subjects suffering from any one of the following heart diseases: a. having uncontrolled or serious cardiovascular and cerebrovascular disease, including the development of grade II ( , NYHA) or above congestive heart failure, unstable angina, acute myocardial infarction within 6 months before the first drug administration, or cardiac arrhythmias requiring treatment at screening; With b. hypertension (systolic pressure≥ 160mmHg and / or diastolic v≥ 100mmHg), and after the combination of two or more antihypertensive drugs can not be reduced to the normal range; or c.with a history of abnormalities, the QRS time was> 120ms, Long syndrome: QTc interval> 450ms in male or QTc interval> 470ms in female.

12.Participated in a clinical study involving the administration, device, or surgery of the study drug (new chemical entity) within 90 days or 5 half-lives (whichever is longer) 13.Patients with a previous history of , or any of the following indicators are positive at screening: hepatitis B virus surface antigen (HBsAg), virus (HCV) antibody, (HIV) antibody, or treponema pallidum antibody.

14.The subject is not fit to participate in the study if the investigator considers. Or the subject could not participate in the trial for his own reasons, or the behavior subject may interfere with treatment, study or interpretation of results (e. g., previous treatment with high-dose aminoglycosides).

Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    TJ0113 group

    Participants will be treated with TJ0113 capsule 200 mg daily for up to 24 weeks

    Drug: TJ0113 capsules

  • Placebo comparator
    Placebo group

    Participants will be treated with a placebo 200 mg daily for up to 24 weeks

    Drug: Placebo capsules

Interventions

  • 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 .

  • DrugPlacebo 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 .

06

What researchers measure

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 discontinuation

Secondary 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 weeks

  2. 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 weeks

  3. 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 weeks

Other 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 weeks

  2. 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 weeks

  3. 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 weeks

  4. 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 weeks

  5. Depression levels

    To compare the change in depression levels using face to face Interview for the Geriatric depression scale-15 (GDS-15) scores.

    Time frame: From baseline to 4, 12 and 24 weeks

  6. Cognition

    To compare the change in cognition by Montreal cognitive gssessment (MoCA) using face to face Interview for the scores.

    Time frame: From baseline to 4, 12 and 24 weeks

  7. Plasma Senescence-associated secretory factor (SASP)

    The absolute values of changes in the levels of plasma Senescence-associated secretory factor (SASP) related to the mechanism. The concentration of the plasma Senescence-associated secretory factor will be measured.

    Time frame: From baseline to 24 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07012746
Lead sponsor
Yilai Shu
Collaborators
Hangzhou PhecdaMed Co., Ltd.
Responsible party
Yilai Shu (Principal Investigator, Eye & ENT Hospital of Fudan University) — Sponsor-investigator
First posted
Jun 10, 2025
Start date
Jun 7, 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Apr 2027 (estimated)
Last update
Jun 10, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: TJ0113

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