PresbycusisPhase 2RLDPNCT05125081

Efficacy and Safety of Liuwei Dihuang Pill Versus Placebo in Presbycusis With Shen (Kidney)-Yin Deficiency

A Phase 2 study testing Liuwei Dihuang Pill (marketed product in China) in people with Presbycusis and Age-related Hearing Loss, run by Shanghai Jiao Tong University School of Medicine at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to examine the effects and safety of Liuwei Dihuang pill and placebo in presbycusis with Shen (kidney)-yin deficiency. Read more about this study

Who is it for?: Ages 65 to 75 years
Conditions the study is for: Presbycusis, Age-related Hearing Loss, Hearing Disorders and Deafness
What is being tested?: Liuwei Dihuang Pill (marketed product in China)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 6 sitesChina
Study dates: 25 Jan 2022to 25 Dec 2024
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 75 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

Subjects must have a current diagnosis of presbyacusis with symmetrical hearing loss, defined as 15-dB or less difference in pure tone average between ears at 0.5, 1, 2 and 4kHz. The average hearing threshold loss level is mild or moderate (20 ≤ average hearing threshold < 50 dBHL).
Adult aged 65-75 years inclusive.
Maximum speech recognition rate in quiet environment is equal to or over 60% with ability to communicate well.
Subjects have no cognitive impairment with CDR score =0.
Subjects must have a current diagnosis of Shen (Kidney)-Yin Deficiency.
Subjects have read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.

Who cannot join

Subjects with sudden hearing loss or pure tone hearing fluctuation within the three months.
Subjects with a history of serious mental illness.
Subjects with severe cardiac insufficiency, malignant tumor or other serious systemic diseases.
Subjects with conductive deafness, congenital deafness, hereditary deafness, inner ear immune and autoimmune inner ear diseases, auditory neuropathy, toxic deafness and noise deafness.
Subjects with organic ear diseases, abnormal ear structure and symptomatic cerebral infarction.
Subjects with dementia, neurosyphilis, hypothyroidism and depression.

Show all 9Show fewer

Subjects has previously participated in other clinical trial within the three months.
Subjects with using hearing aids or devices.
Other situations where the researcher thinks it is inappropriate to participate in this research.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Community Health Service Center of North Sichuan Road, Hongkou District, Shanghai
Shanghai, Shanghai Municipality, 200081
Jiaxing Street Community Health Service Center, Hongkou District, Shanghai
Shanghai, Shanghai Municipality, 200086
Community Health Service Center of Tianlin Street, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, 200233
Sixth people's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200233
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437
Juquan New Town Community Health Service Center, Gucun Town, Baoshan District, Shanghai
Shanghai, Shanghai Municipality, 201907

Other trials in China

About this study

Official title: RCT Study of Liuwei Dihuang Pill Preventing and Treating Presbycusis With Shen (Kidney)-Yin Deficiency

The objective of this study is to examine the effects and safety of Liuwei Dihuang pill and placebo in presbycusis with Shen (kidney)-yin deficiency.

Read the detailed description

There are no approved pharmacologic therapies for age-related hearing loss (ARHL), also known as presbycusis. Based on the syndrome differentiation in Chinese medicine (CM) theory, the pathogenesis of presbycusis is related to the Shen (kidney)-yin deficiency. Liuwei Dihuang Pill (LDP) is effective and commonly prescribed for the treatment of Shen-yin deficiency.

The main purpose of this study is to try to demonstrate an improvement in phonetically balanced maximum (PBmax) after 1 years of treatment with the LDP versus the placebo. Subjects will undergo a safety follow-up after the treatment period. Safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.).The amount of drug in the blood will also be measured.

It is expected that around 120 people (at least 60 in each arm) with presbycusis with Shen (kidney)-yin deficiency may take part in the study. The study participants will be recruited at around 6 sites in the Shanghai, China.

Conditions: Presbycusis, Age-related Hearing Loss, Hearing Disorders and Deafness
Being tested: Liuwei Dihuang Pill (marketed product in China), Liuwei Dihuang Pill（placebo ）
Keywords: Presbycusis, Age-related hearing loss, Liuwei Dihuang Pill
Medical subject headings: Presbycusis, Hearing Disorders, Deafness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Liuwei Dihuang Pill (marketed product in China)Drug
Also called Liu Wei Di Huang Pill
LDP group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo group and LDP group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the LDP group and placebo group at a ratio of 1:1. The drug was administered for 48 weeks, 3 times a day, 8 pills each time.
Liuwei Dihuang Pill（placebo ）Drug
Also called placebo group
LDP group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo group and LDP group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the LDP group and placebo group at a ratio of 1:1. The drug was administered for 48 weeks, 3 times a day, 8 pills each time.

Study groups in NCT05125081
Study group	Role	What they receive
LDP group	Experimental	Liuwei Dihuang Pill (LDP）marketed product in China donated by pharmaceutical company. Receives: Drug: Liuwei Dihuang Pill (marketed product in China)
placebo group	Placebo comparator	Same smell, color and shape as Liuwei Dihuang Pill (LDP）without herbs in capsules. Receives: Drug: Liuwei Dihuang Pill（placebo ）

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in PB-Max after 48 weeks of treatment
To compare the change in PB-Max using the Word Recognition in Quiet test measured with Consonant-Nucleus-Consonant (CNC) word lists from baseline (week 1 to week 48) between LDP and placebo.
Measured: 48 weeks

Secondary outcomes (5)

Change in Speech recognition threshold (SRT) after 24 weeks and 48 weeks of treatment
To compare the change in Speech recognition threshold (SRT) using the Word Recognition in Quiet test measured with Consonant-Nucleus-Consonant (CNC) word lists from baseline (week 1 to week 24，week 48) between LDP and placebo.
Measured: 24 weeks，48 weeks
Change in Pure Tone Average (PTA) after 24 weeks and 48 weeks of treatment
To compare the change in Pure Tone Average (PTA) using the Air conduction audiometry for hearing at certain range (Hz) from baseline (week 1 to week 24，week 48) between LDP and placebo.
Measured: 24 weeks，48 weeks
Change in Shen (Kidney)-Yin Deficiency Syndrome Questionnaire after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment
To compare the change in Shen (Kidney)-Yin Deficiency Syndrome Questionnaire using Face to face Interview for the scores from baseline (week 1 to week 12，week 24，week 36 and week 48) between LDP and placebo (range, 0 [best] to 100 [worst]).
Measured: 12 weeks，24 weeks，36 weeks，48 weeks
Change in Tinnitus Handicap Inventory（THI）after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment
To compare the change in Tinnitus Handicap Inventory（THI）using Face to face Interview for the scores from baseline (week 1 to week 12，week 24，week 36 and week 48) between LDP and placebo (range, 0 [best] to 100 [worst]).
Measured: 12 weeks，24 weeks，36 weeks，48 weeks
Change in Mini-mental State Examination (MMSE) after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment
To compare the change in Mini-mental State Examination (MMSE) using Face to face Interview for the scores from baseline (week 1 to week 12，week 24，week 36 and week 48) between LDP and placebo (range, 0 [worst] to 100 [best]).
Measured: 12 weeks，24 weeks，36 weeks，48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 202225 Dec 2024

First posted18 Nov 2021
Study start25 Jan 2022
Primary completion7 Aug 2024
Study completion25 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for PresbycusisStudies of the same condition, open and under way.
More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study of Liuwei Dihuang Pill Administered by taking orally in Adults With Presbycusis With Shen (Kidney)-Yin Deficiency.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05125081
Sponsor's protocol ID: RLDP-2021
Acronym: RLDP
Status last verified: Jan 2026
First submitted: 17 Nov 2021
Last updated: 7 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Bednar MM, DeMartinis N, Banerjee A, Bowditch S, Gaudreault F, Zumpano L, Lin FR. The Safety and Efficacy of PF-04958242 in Age-Related Sensorineural Hearing Loss: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Jul;141(7):607-13. doi: 10.1001/jamaoto.2015.0791.
PubMed 25997115
McLean WJ, Hinton AS, Herby JTJ, Salt AN, Hartsock JJ, Wilson S, Lucchino DL, Lenarz T, Warnecke A, Prenzler N, Schmitt H, King S, Jackson LE, Rosenbloom J, Atiee G, Bear M, Runge CL, Gifford RH, Rauch SD, Lee DJ, Langer R, Karp JM, Loose C, LeBel C. Improved Speech Intelligibility in Subjects With Stable Sensorineural Hearing Loss Following Intratympanic Dosing of FX-322 in a Phase 1b Study. Otol Neurotol. 2021 Aug 1;42(7):e849-e857. doi: 10.1097/MAO.0000000000003120.
PubMed 33617194
Ge JR, Xie LH, Chen J, Li SQ, Xu HJ, Lai YL, Qiu LL, Ni CB. Liuwei Dihuang Pill () Treats Postmenopausal Osteoporosis with Shen (Kidney) Yin Deficiency via Janus Kinase/Signal Transducer and Activator of Transcription Signal Pathway by Up-regulating Cardiotrophin-Like Cytokine Factor 1 Expression. Chin J Integr Med. 2018 Jun;24(6):415-422. doi: 10.1007/s11655-016-2744-2. Epub 2016 Dec 27.
PubMed 28028720

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Barriers and Facilitators to OTC Hearing Aids Success
Hearing Loss, Sensorineural, Presbycusis
Not yet recruitingPhase 1/2
First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
Sensorineural Hearing Loss, Presbyacusis
Not yet recruitingObservational study
Optimizing Elderly Hearing Loss Care in Hong Kong A Cost-Effectiveness and Satisfactory Analysis of a Pilot Collaborative Model Between Otorhinolaryngologists and Family Medicine Specialists
Hearing Loss, Age-Related, Presbycusis
Active, not recruiting
Hearing Healthcare Assessment in Rural Communities
Hearing Loss, Adult-Onset, Hearing Loss, Age-Related
Recruiting
Early Age-Related Hearing Loss Investigation (EARHLI)
Alzheimer Disease, Hearing Loss

All Presbycusis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RCT Study of Liuwei Dihuang Pill Preventing and Treating Presbycusis With Shen (Kidney)-Yin Deficiency
ClinicalTrials.gov ID: NCT05125081
Acronym / sponsor ID: RLDP / RLDP-2021
Conditions: Presbycusis, Age-related Hearing Loss, Hearing Disorders and Deafness
Keywords: Presbycusis, Age-related hearing loss, Liuwei Dihuang Pill
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Collaborators: Shanghai University of Traditional Chinese Medicine
Study start: 25 Jan 2022 (actual)
Primary completion: 7 Aug 2024 (actual)
Study completion: 25 Dec 2024 (actual)
First posted: 18 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to examine the effects and safety of Liuwei Dihuang pill and placebo in presbycusis with Shen (kidney)-yin deficiency.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study of Liuwei Dihuang Pill Administered by taking orally in Adults With Presbycusis With Shen (Kidney)-Yin Deficiency.

Arm	Type	Receives
LDP group	Experimental	Drug: Liuwei Dihuang Pill (marketed product in China)Liuwei Dihuang Pill (LDP）marketed product in China donated by pharmaceutical company.
placebo group	Placebo comparator	Drug: Liuwei Dihuang Pill（placebo ）Same smell, color and shape as Liuwei Dihuang Pill (LDP）without herbs in capsules.

Who may qualify

Ages: 65 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

Subjects must have a current diagnosis of presbyacusis with symmetrical hearing loss, defined as 15-dB or less difference in pure tone average between ears at 0.5, 1, 2 and 4kHz. The average hearing threshold loss level is mild or moderate (20 ≤ average hearing threshold < 50 dBHL).
Adult aged 65-75 years inclusive.
Maximum speech recognition rate in quiet environment is equal to or over 60% with ability to communicate well.
Subjects have no cognitive impairment with CDR score =0.
Subjects must have a current diagnosis of Shen (Kidney)-Yin Deficiency.

Key exclusion criteria (9 listed)

Subjects with sudden hearing loss or pure tone hearing fluctuation within the three months.
Subjects with a history of serious mental illness.
Subjects with severe cardiac insufficiency, malignant tumor or other serious systemic diseases.
Subjects with conductive deafness, congenital deafness, hereditary deafness, inner ear immune and autoimmune inner ear diseases, auditory neuropathy, toxic deafness and noise deafness.
Subjects with organic ear diseases, abnormal ear structure and symptomatic cerebral infarction.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Liuwei Dihuang Pill (marketed product in China)Also: Liu Wei Di Huang PillLDP group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo group and LDP group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the LDP group and placebo group at a ratio of 1:1. The drug was administered for 48 weeks, 3 times a day, 8 pills each time.	Drug	LDP group
Liuwei Dihuang Pill（placebo ）Also: placebo groupLDP group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo group and LDP group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the LDP group and placebo group at a ratio of 1:1. The drug was administered for 48 weeks, 3 times a day, 8 pills each time.	Drug	placebo group

Primary outcome

Change in PB-Max after 48 weeks of treatment
Time frame: 48 weeks
To compare the change in PB-Max using the Word Recognition in Quiet test measured with Consonant-Nucleus-Consonant (CNC) word lists from baseline (week 1 to week 48) between LDP and placebo.

5 secondary outcomes

Change in Speech recognition threshold (SRT) after 24 weeks and 48 weeks of treatment
Time frame: 24 weeks，48 weeks
Change in Pure Tone Average (PTA) after 24 weeks and 48 weeks of treatment
Time frame: 24 weeks，48 weeks
Change in Shen (Kidney)-Yin Deficiency Syndrome Questionnaire after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment
Time frame: 12 weeks，24 weeks，36 weeks，48 weeks
Change in Tinnitus Handicap Inventory（THI）after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment
Time frame: 12 weeks，24 weeks，36 weeks，48 weeks
Change in Mini-mental State Examination (MMSE) after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment
Time frame: 12 weeks，24 weeks，36 weeks，48 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
Background: PubMed 25997115Bednar MM, DeMartinis N, Banerjee A, Bowditch S, Gaudreault F, Zumpano L, Lin FR. The Safety and Efficacy of PF-04958242 in Age-Related Sensorineural Hearing Loss: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Jul;141(7):607-13. doi: 10.1001/jamaoto.2015.0791.
Background: PubMed 33617194McLean WJ, Hinton AS, Herby JTJ, Salt AN, Hartsock JJ, Wilson S, Lucchino DL, Lenarz T, Warnecke A, Prenzler N, Schmitt H, King S, Jackson LE, Rosenbloom J, Atiee G, Bear M, Runge CL, Gifford RH, Rauch SD, Lee DJ, Langer R, Karp JM, Loose C, LeBel C. Improved Speech Intelligibility in Subjects With Stable Sensorineural Hearing Loss Following Intratympanic Dosing of FX-322 in a Phase 1b Study. Otol Neurotol. 2021 Aug 1;42(7):e849-e857. doi: 10.1097/MAO.0000000000003120.
Background: PubMed 28028720Ge JR, Xie LH, Chen J, Li SQ, Xu HJ, Lai YL, Qiu LL, Ni CB. Liuwei Dihuang Pill () Treats Postmenopausal Osteoporosis with Shen (Kidney) Yin Deficiency via Janus Kinase/Signal Transducer and Activator of Transcription Signal Pathway by Up-regulating Cardiotrophin-Like Cytokine Factor 1 Expression. Chin J Integr Med. 2018 Jun;24(6):415-422. doi: 10.1007/s11655-016-2744-2. Epub 2016 Dec 27.
《The World Report on Hearing》2021Link provided by the sponsor.

Related trials for Presbycusis

Recruiting
Barriers and Facilitators to OTC Hearing Aids Success
Hearing Loss, Sensorineural, Presbycusis
Not yet recruitingPhase 1/2
First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
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Not yet recruitingObservational study
Optimizing Elderly Hearing Loss Care in Hong Kong A Cost-Effectiveness and Satisfactory Analysis of a Pilot Collaborative Model Between Otorhinolaryngologists and Family Medicine Specialists
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Active, not recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jianrong Shi, Doctor study director

Shanghai Jiao Tong University School of Medicine

Jianning Zhang, Doctor principal investigator

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Ping Huang, Doctor principal investigator

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PB-Max after 48 weeks of treatment (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05125081, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.