Back to resultsEfficacy and Safety of Liuwei Dihuang Pill Versus Placebo in Presbycusis With Shen (Kidney)-Yin Deficiency (RLDP)
Primary Purpose
Presbycusis, Age-related Hearing Loss, Hearing Disorders and Deafness
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Liuwei Dihuang Pill (marketed product in China)
Liuwei Dihuang Pill（placebo ）
Sponsored by
About this trial
This is an interventional treatment trial for Presbycusis focused on measuring Presbycusis, Age-related hearing loss, Liuwei Dihuang Pill
Eligibility Criteria
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.
Sites / Locations
- Community Health Service Center of North Sichuan Road, Hongkou District, ShanghaiRecruiting
- Jiaxing Street Community Health Service Center, Hongkou District, ShanghaiRecruiting
- Community Health Service Center of Tianlin Street, Xuhui District, ShanghaiRecruiting
- Sixth people's Hospital Affiliated to Shanghai Jiaotong UniversityRecruiting
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese MedicineRecruiting
- Juquan New Town Community Health Service Center, Gucun Town, Baoshan District, ShanghaiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LDP group
placebo group
Arm Description
Liuwei Dihuang Pill (LDP）marketed product in China donated by pharmaceutical company.
Same smell, color and shape as Liuwei Dihuang Pill (LDP）without herbs in capsules.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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]).
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]).
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]).
Full Information
NCT ID
NCT05125081
First Posted
November 17, 2021
Last Updated
August 7, 2023
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05125081
Brief Title
Efficacy and Safety of Liuwei Dihuang Pill Versus Placebo in Presbycusis With Shen (Kidney)-Yin Deficiency
Acronym
RLDP
Official Title
RCT Study of Liuwei Dihuang Pill Preventing and Treating Presbycusis With Shen (Kidney)-Yin Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbycusis, Age-related Hearing Loss, Hearing Disorders and Deafness
Keywords
Presbycusis, Age-related hearing loss, Liuwei Dihuang Pill
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LDP group
Arm Type
Experimental
Arm Description
Liuwei Dihuang Pill (LDP）marketed product in China donated by pharmaceutical company.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Same smell, color and shape as Liuwei Dihuang Pill (LDP）without herbs in capsules.
Intervention Type
Drug
Intervention Name(s)
Liuwei Dihuang Pill (marketed product in China)
Other Intervention Name(s)
Liu Wei Di Huang Pill
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Liuwei Dihuang Pill（placebo ）
Other Intervention Name(s)
placebo group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PB-Max after 48 weeks of treatment
Description
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
Secondary Outcome Measure Information:
Title
Change in Speech recognition threshold (SRT) after 24 weeks and 48 weeks of treatment
Description
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
Title
Change in Pure Tone Average (PTA) after 24 weeks and 48 weeks of treatment
Description
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
Title
Change in Shen (Kidney)-Yin Deficiency Syndrome Questionnaire after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment
Description
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
Title
Change in Tinnitus Handicap Inventory（THI）after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment
Description
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
Title
Change in Mini-mental State Examination (MMSE) after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment
Description
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
Other Pre-specified Outcome Measures:
Title
Change in ABR after 48 weeks of treatment
Description
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
Title
Change in DPOAE pass rate after 48 weeks of treatment
Description
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
Title
Change in serum CRP after 48 weeks of treatment
Description
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
Title
Change in serum IL6 after 48 weeks of treatment
Description
The absolute values of changes in the levels of serum interleukin 6 (IL-6) related to the mechanism from baseline (week 1 to week 48) between LDP and placebo.
Time Frame
48 weeks
Title
Change in serum TNF-α after 48 weeks of treatment
Description
The absolute values of changes in the levels of serum Tumor necrosis factor (TNF-α) related to the mechanism from baseline (week 1 to week 48) between LDP and placebo.
Time Frame
48 weeks
Title
Change in serum MDA after 48 weeks of treatment
Description
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
Title
Change in serum MPO after 48 weeks of treatment
Description
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
Title
Change in serum GSH after 48 weeks of treatment
Description
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
Title
Change in serum T-AOC after 48 weeks of treatment
Description
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
Title
Change in serum NfL after 48 weeks of treatment
Description
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
Title
Change in hemodynamic signals of resting fMRI after 48 weeks of treatment
Description
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
Title
Adverse Events
Description
Incidence of adverse events.
Time Frame
24 weeks，48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianrong Shi, Doctor
Phone
86-21-63846590
Ext
776298
Email
sjr@shsmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hongsheng Tan, Doctor
Phone
86-21-63846590
Ext
776747
Email
tanhs@shsmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianrong Shi, Doctor
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jianning Zhang, Doctor
Organizational Affiliation
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ping Huang, Doctor
Organizational Affiliation
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hongsheng Tan, Doctor
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health Service Center of North Sichuan Road, Hongkou District, Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leifang Shen, Doctor
Phone
13818024963
Email
scbywk@163.com
First Name & Middle Initial & Last Name & Degree
Yi Jiang
Phone
13564102791
Email
jiangyi_tcm@163.com
First Name & Middle Initial & Last Name & Degree
Shen Leifang
First Name & Middle Initial & Last Name & Degree
Jiang Yi
Facility Name
Jiaxing Street Community Health Service Center, Hongkou District, Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200086
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Xiao, Doctor
Phone
18930820520
Email
hkjxywk@163.com
First Name & Middle Initial & Last Name & Degree
Qing Peng
Phone
18930821850
Email
13611951897@139.com
First Name & Middle Initial & Last Name & Degree
Xiao Nan
First Name & Middle Initial & Last Name & Degree
Peng Qing
Facility Name
Community Health Service Center of Tianlin Street, Xuhui District, Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiwei Lv, Doctor
Phone
13601692800
Email
13601692800@163.com
First Name & Middle Initial & Last Name & Degree
Yanling Lian
Phone
13564830300
Email
lianhuakai1984@126.com
First Name & Middle Initial & Last Name & Degree
Qiwei Lv
First Name & Middle Initial & Last Name & Degree
Lian Yanling
Facility Name
Sixth people's Hospital Affiliated to Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengxi Meng, Doctor
Phone
18930170565
Email
mengsx163@163.com
First Name & Middle Initial & Last Name & Degree
Zhonghai Yu
Phone
18930174652
Email
yuzhonghai0715@126.com
First Name & Middle Initial & Last Name & Degree
Shengxi Meng
First Name & Middle Initial & Last Name & Degree
Zhonghai Yu
Facility Name
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200437
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JIanning Zhang, Doctor
Phone
18930568790
Email
eternityz@sina.com
First Name & Middle Initial & Last Name & Degree
Ping Huang, Doctor
Phone
13311707029
Email
m13311707029@163.com
First Name & Middle Initial & Last Name & Degree
Jianning Zhang, Doctor
First Name & Middle Initial & Last Name & Degree
Ping Huang, Doctor
First Name & Middle Initial & Last Name & Degree
Yan Huo, Doctor
First Name & Middle Initial & Last Name & Degree
Zhuwen Zheng, Master
First Name & Middle Initial & Last Name & Degree
Peipei Xu, Master
First Name & Middle Initial & Last Name & Degree
Huan Tang, Master
First Name & Middle Initial & Last Name & Degree
Li Yan, Doctor
Facility Name
Juquan New Town Community Health Service Center, Gucun Town, Baoshan District, Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201907
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuhui Wu, Doctor
Phone
13816938482
Email
wsh-1227@163.com
First Name & Middle Initial & Last Name & Degree
Yujia Li
Phone
13941654087
Email
1104429435@qq.com
First Name & Middle Initial & Last Name & Degree
Shuhui Wu
First Name & Middle Initial & Last Name & Degree
Yujia Li
First Name & Middle Initial & Last Name & Degree
Tai Zhang
First Name & Middle Initial & Last Name & Degree
Huafang Dong
12. IPD Sharing Statement
Citations:
PubMed Identifier
25997115
Citation
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.
Results Reference
background
PubMed Identifier
33617194
Citation
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.
Results Reference
background
PubMed Identifier
28028720
Citation
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.
Results Reference
background
Links:
URL
https://www.who.int/publications/i/item/world-report-on-hearing
Description
《The World Report on Hearing》2021
Learn more about this trial
Efficacy and Safety of Liuwei Dihuang Pill Versus Placebo in Presbycusis With Shen (Kidney)-Yin Deficiency
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