A Phase 2 interventional study of Liuwei Dihuang Pill (marketed product in China) and Liuwei Dihuang Pill（placebo ） in Presbycusis, Age-related Hearing Loss and Hearing Disorders and Deafness, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 6 sites in China. Open to participants aged 65 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment
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.
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.
66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 45 interventional studies indexed under Presbycusis.
Browse Presbycusis studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
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.
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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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Liuwei Dihuang Pill (LDP）marketed product in China donated by pharmaceutical company.
Drug: Liuwei Dihuang Pill (marketed product in China)
Same smell, color and shape as Liuwei Dihuang Pill (LDP）without herbs in capsules.
Drug: Liuwei Dihuang Pill（placebo ）
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.
Also known as: 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.
Also known as: placebo group
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.
Time frame: 48 weeks
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.
Time frame: 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.
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
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 \[worst\]).
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
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 \[worst\]).
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
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 \[best\]).
Time frame: 12 weeks，24 weeks，36 weeks，48 weeks
Change in ABR after 48 weeks of treatment
The absolute values of changes in the levels of auditory brainstem response（ABR ）from baseline (week 1 to week 48) between LDP and placebo.
Time frame: 48 weeks
Change in DPOAE pass rate after 48 weeks of treatment
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.
Time frame: 48 weeks
Change in serum CRP after 48 weeks of treatment
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.
Time frame: 48 weeks
Change in serum cytokines after 48 weeks of treatment
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.
Time frame: 48 weeks
Change in Peripheral Blood Mononuclear Cells after 48 weeks of treatment
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.
Time frame: 48 weeks
Change in serum MDA after 48 weeks of treatment
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.
Time frame: 48 weeks
Change in serum MPO after 48 weeks of treatment
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.
Time frame: 48 weeks
Change in serum GSH after 48 weeks of treatment
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.
Time frame: 48 weeks
Change in serum T-AOC after 48 weeks of treatment
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.
Time frame: 48 weeks
Change in serum NfL after 48 weeks of treatment
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.
Time frame: 48 weeks
Change in Composite indictors after 48 weeks of treatment
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.
Time frame: 48 weeks
Change in hemodynamic signals of resting fMRI after 48 weeks of treatment
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.
Time frame: 48 weeks
Change in perpheral metabolomics after 48 weeks of treatment
To compare the change in perpheral metabolomics from baseline(week 1 to week 48) between LDP and placebo.
Time frame: 48 weeks
Change in perpheral proteomics after 48 weeks of treatment
To compare the change in perpheral proteomics from baseline(week 1 to week 48) between LDP and placebo.
Time frame: 48 weeks
Adverse Events
Incidence of adverse events.
Time frame: 24 weeks，48 weeks
Ran from Jan 2022 to primary completion in Aug 2024, 30 months.
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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