Efficacy and Safety of Liuwei Dihuang Pill Versus Placebo in Presbycusis With Shen (Kidney)-Yin Deficiency (RLDP)

August 7, 2023 updated by: Jianrong Shi, Shanghai Jiao Tong University School of Medicine

RCT Study of Liuwei Dihuang Pill Preventing and Treating 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hongsheng Tan, Doctor
  • Phone Number: 776747 86-21-63846590
  • Email: tanhs@shsmu.edu.cn

Study Contact Backup

  • Name: Jianrong Shi, Doctor
  • Phone Number: 776298 86-21-63846590
  • Email: sjr@shsmu.edu.cn

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200437
        • Recruiting
        • Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jianning Zhang, Doctor
        • Principal Investigator:
          • Ping Huang, Doctor
        • Sub-Investigator:
          • Yan Huo, Doctor
        • Sub-Investigator:
          • Zhuwen Zheng, Master
        • Sub-Investigator:
          • Peipei Xu, Master
        • Sub-Investigator:
          • Huan Tang, Master
        • Sub-Investigator:
          • Li Yan, Doctor
      • Shanghai, Shanghai, China, 200081
        • Recruiting
        • Community Health Service Center of North Sichuan Road, Hongkou District, Shanghai
        • Contact:
          • Leifang Shen, Doctor
          • Phone Number: 13818024963
          • Email: scbywk@163.com
        • Contact:
        • Principal Investigator:
          • Shen Leifang
        • Sub-Investigator:
          • Jiang Yi
      • Shanghai, Shanghai, China, 200086
        • Recruiting
        • Jiaxing Street Community Health Service Center, Hongkou District, Shanghai
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiao Nan
        • Sub-Investigator:
          • Peng Qing
      • Shanghai, Shanghai, China, 200233
        • Recruiting
        • Community Health Service Center of Tianlin Street, Xuhui District, Shanghai
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qiwei Lv
        • Sub-Investigator:
          • Lian Yanling
      • Shanghai, Shanghai, China, 200233
        • Recruiting
        • Sixth people's Hospital Affiliated to Shanghai Jiaotong University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shengxi Meng
        • Sub-Investigator:
          • Zhonghai Yu
      • Shanghai, Shanghai, China, 201907
        • Recruiting
        • Juquan New Town Community Health Service Center, Gucun Town, Baoshan District, Shanghai
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuhui Wu
        • Principal Investigator:
          • Yujia Li
        • Sub-Investigator:
          • Tai Zhang
        • Sub-Investigator:
          • Huafang Dong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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).
  2. Adult aged 65-75 years inclusive.
  3. Maximum speech recognition rate in quiet environment is equal to or over 60% with ability to communicate well.
  4. Subjects have no cognitive impairment with CDR score =0.
  5. Subjects must have a current diagnosis of Shen (Kidney)-Yin Deficiency.
  6. 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:

  1. Subjects with sudden hearing loss or pure tone hearing fluctuation within the three months.
  2. Subjects with a history of serious mental illness.
  3. Subjects with severe cardiac insufficiency, malignant tumor or other serious systemic diseases.
  4. Subjects with conductive deafness, congenital deafness, hereditary deafness, inner ear immune and autoimmune inner ear diseases, auditory neuropathy, toxic deafness and noise deafness.
  5. Subjects with organic ear diseases, abnormal ear structure and symptomatic cerebral infarction.
  6. Subjects with dementia, neurosyphilis, hypothyroidism and depression.
  7. Subjects has previously participated in other clinical trial within the three months.
  8. Subjects with using hearing aids or devices.
  9. Other situations where the researcher thinks it is inappropriate to participate in this research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LDP group
Liuwei Dihuang Pill (LDP）marketed product in China donated by pharmaceutical company.
Drug: Liuwei Dihuang Pill (marketed product in China)
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
Placebo Comparator: placebo group
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.
Other Names:
  • placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks，48 weeks
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.
24 weeks，48 weeks
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]).
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
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]).
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
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]).
12 weeks，24 weeks，36 weeks，48 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 weeks
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.
48 weeks
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.
48 weeks
Change in serum IL6 after 48 weeks of treatment
Time Frame: 48 weeks
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.
48 weeks
Change in serum TNF-α after 48 weeks of treatment
Time Frame: 48 weeks
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.
48 weeks
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.
48 weeks
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.
48 weeks
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.
48 weeks
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.
48 weeks
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.
48 weeks
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.
48 weeks
Adverse Events
Time Frame: 24 weeks，48 weeks
Incidence of adverse events.
24 weeks，48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Hongsheng Tan, Doctor, Shanghai Jiao Tong University School of Medicine
  • Study Director: Jianrong Shi, Doctor, Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2022

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RLDP-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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