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NCT Number: NCT05125081

Efficacy and Safety of Liuwei Dihuang Pill Versus Placebo in 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.

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Key information

Conditions

Presbycusis Age-related Hearing Loss Deafness Ear Diseases Hearing Disorders Hearing Disorders and Deafness Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Community Health Service Center of North Sichuan Road, Hongkou District, Shanghai, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Liuwei Dihuang Pill (marketed product in China)

Drug

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.

Other names: Liu Wei Di Huang Pill

Liuwei Dihuang Pill（placebo ）

Drug

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.

Other names: placebo group

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Speech recognition threshold (SRT) after 24 weeks and 48 weeks of treatment

    Time frame: 24 weeks，48 weeks

    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.

  2. Change in Pure Tone Average (PTA) after 24 weeks and 48 weeks of treatment

    Time frame: 24 weeks，48 weeks

    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.

  3. 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

    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]).

  4. 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

    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]).

  5. 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

    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]).

Other outcomes

  1. Change in ABR after 48 weeks of treatment

    Time frame: 48 weeks

    The absolute values of changes in the levels of auditory brainstem response（ABR ）from baseline (week 1 to week 48) between LDP and placebo.

  2. Change in DPOAE pass rate after 48 weeks of treatment

    Time frame: 48 weeks

    The absolute values of changes in the pass rate levels of distortion product otoacoustic emissions（DPOAE）from baseline (week 1 to week 48) between LDP and placebo.

  3. Change in serum CRP after 48 weeks of treatment

    Time frame: 48 weeks

    The absolute values of changes in the levels of serum C-reactive protein (CRP) related to the mechanism from baseline (week 1 to week 48) between LDP and placebo.

  4. Change in serum cytokines after 48 weeks of treatment

    Time frame: 48 weeks

    The absolute values of changes in the levels of serum cytokines related to the mechanism from baseline (week 1 to week 48) between LDP and placebo.

  5. Change in Peripheral Blood Mononuclear Cells after 48 weeks of treatment

    Time frame: 48 weeks

    The absolute values of changes in the levels of Peripheral Blood Mononuclear Cells related to the mechanism from baseline (week 1 to week 48) between LDP and placebo.

  6. Change in serum MDA after 48 weeks of treatment

    Time frame: 48 weeks

    The absolute values of changes in the levels of serum Malondialdehyde (MDA) related to the mechanism from baseline (week 1 to week 48) between LDP and placebo.

  7. Change in serum MPO after 48 weeks of treatment

    Time frame: 48 weeks

    The absolute values of changes in the levels of serum Myeloperoxidase (MPO) related to the mechanism from baseline (week 1 to week 48) between LDP and placebo.

  8. Change in serum GSH after 48 weeks of treatment

    Time frame: 48 weeks

    The absolute values of changes in the levels of serum L-Glutathione(GSH) related to the mechanism from baseline (week 1 to week 48) between LDP and placebo.

  9. Change in serum T-AOC after 48 weeks of treatment

    Time frame: 48 weeks

    The absolute values of changes in the levels of serum Total antioxidant capacity（T-AOC）related to the mechanism from baseline (week 1 to week 48) between LDP and placebo.

  10. Change in serum NfL after 48 weeks of treatment

    Time frame: 48 weeks

    The absolute values of changes in the levels of serum Neurofilament Light（NfL）related to the mechanism from baseline (week 1 to week 48) between LDP and placebo.

  11. Change in Composite indictors after 48 weeks of treatment

    Time frame: 48 weeks

    To compare the changes in Composite indictors (some individual indicators are compiled into a single index on the basis of an underlying model according to specific evaluation) from baseline (week 1 to week 48) between LDP and placebo.

  12. Change in hemodynamic signals of resting fMRI after 48 weeks of treatment

    Time frame: 48 weeks

    The changes in hemodynamic signals of resting functional magnetic resonance imaging (fMRI) related to the mechanism from baseline (week 1 to week 48) between LDP and placebo. 40 patients were selected for this study.

  13. Change in perpheral metabolomics after 48 weeks of treatment

    Time frame: 48 weeks

    To compare the change in perpheral metabolomics from baseline(week 1 to week 48) between LDP and placebo.

  14. Change in perpheral proteomics after 48 weeks of treatment

    Time frame: 48 weeks

    To compare the change in perpheral proteomics from baseline(week 1 to week 48) between LDP and placebo.

  15. Adverse Events

    Time frame: 24 weeks，48 weeks

    Incidence of adverse events.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Shanghai University of Traditional Chinese Medicine

Registry information

Official study title

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

Acronym: RLDP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2021
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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