NCT05125081

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2022

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 25, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2024

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

November 17, 2021

Last Update Submit

January 5, 2026

Conditions

PresbycusisAge-related Hearing LossHearing Disorders and Deafness

Keywords

PresbycusisAge-related hearing lossLiuwei Dihuang Pill

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

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

    24 weeks，48 weeks

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

    24 weeks，48 weeks

  • Change in Shen (Kidney)-Yin Deficiency Syndrome Questionnaire after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment

    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

    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

    12 weeks，24 weeks，36 weeks，48 weeks

Other Outcomes (15)

  • Change in ABR after 48 weeks of treatment

    48 weeks

  • Change in DPOAE pass rate after 48 weeks of treatment

    48 weeks

  • Change in serum CRP after 48 weeks of treatment

    48 weeks

  • +12 more other outcomes

Study Arms (2)

LDP group

EXPERIMENTAL

Liuwei Dihuang Pill (LDP）marketed product in China donated by pharmaceutical company.

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.

Drug: Liuwei Dihuang Pill（placebo ）

Interventions

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.

Also known as: placebo group
placebo group
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.

Also known as: Liu Wei Di Huang Pill
LDP group

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

Shanghai, Shanghai Municipality, 200081, China

Location

Jiaxing Street Community Health Service Center, Hongkou District, Shanghai

Shanghai, Shanghai Municipality, 200086, China

Location

Community Health Service Center of Tianlin Street, Xuhui District, Shanghai

Shanghai, Shanghai Municipality, 200233, China

Location

Sixth people's Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200233, China

Location

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200437, China

Location

Juquan New Town Community Health Service Center, Gucun Town, Baoshan District, Shanghai

Shanghai, Shanghai Municipality, 201907, China

Location

Related Publications (3)

  • 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.

    PMID: 25997115BACKGROUND

  • 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.

    PMID: 33617194BACKGROUND

  • 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.

    PMID: 28028720BACKGROUND

Related Links

MeSH Terms

Conditions

PresbycusisHearing DisordersDeafness

Interventions

Liuwei Dihuang Decoction

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing LossEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor&Vice-Principal

Study Record Dates

First Submitted

November 17, 2021

First Posted

November 18, 2021

Study Start

January 25, 2022

Primary Completion

August 7, 2024

Study Completion

December 25, 2024

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations

CN(6)