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| Name | Class |
|---|---|
| Shanghai University of Traditional Chinese Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDP group | Experimental | Liuwei Dihuang Pill (LDP）marketed product in China donated by pharmaceutical company. |
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| placebo group | Placebo Comparator | Same smell, color and shape as Liuwei Dihuang Pill (LDP）without herbs in capsules. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks，48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 weeks |
| Change in DPOAE pass rate after 48 weeks of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianrong Shi, Doctor | Shanghai Jiao Tong University School of Medicine | Study Director |
| Jianning Zhang, Doctor | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine | Principal Investigator |
| Ping Huang, Doctor | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine | Principal Investigator |
| Hongsheng Tan, Doctor | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health Service Center of North Sichuan Road, Hongkou District, Shanghai | Shanghai | Shanghai Municipality | 200081 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25997115 | Background | 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. | |
| 33617194 | Background | 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. |
| Label | URL |
|---|---|
| 《The World Report on Hearing》2021 | View source |
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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.
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| 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. |
|
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| 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. |
| 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]). | 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]). | 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]). | 12 weeks，24 weeks，36 weeks，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.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 48 weeks |
| Adverse Events | Incidence of adverse events. | 24 weeks，48 weeks |
| Jiaxing Street Community Health Service Center, Hongkou District, Shanghai |
| Shanghai |
| Shanghai Municipality |
| 200086 |
| China |
| Community Health Service Center of Tianlin Street, Xuhui District, Shanghai | Shanghai | Shanghai Municipality | 200233 | China |
| Sixth people's Hospital Affiliated to Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200233 | China |
| Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 200437 | China |
| Juquan New Town Community Health Service Center, Gucun Town, Baoshan District, Shanghai | Shanghai | Shanghai Municipality | 201907 | China |
| 28028720 | Background | 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. |
| ID | Term |
|---|---|
| D011304 | Presbycusis |
| D006311 | Hearing Disorders |
| D003638 | Deafness |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C042579 | Liuwei Dihuang Decoction |
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