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

Last updated: July 3, 2024
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

2

Condition

Deafness

Aging

Hearing Impairment

Treatment

Liuwei Dihuang Pill(placebo )

Liuwei Dihuang Pill (marketed product in China)

Clinical Study ID

NCT05125081
RLDP-2021
  • Ages 65-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects must have a current diagnosis of presbyacusis with symmetrical hearingloss, 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% withability 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 allquestions have been answered and prior to any study-mandated procedure.

Exclusion

Exclusion Criteria:

  1. Subjects with sudden hearing loss or pure tone hearing fluctuation within the threemonths.

  2. Subjects with a history of serious mental illness.

  3. Subjects with severe cardiac insufficiency, malignant tumor or other serioussystemic diseases.

  4. Subjects with conductive deafness, congenital deafness, hereditary deafness, innerear immune and autoimmune inner ear diseases, auditory neuropathy, toxic deafnessand noise deafness.

  5. Subjects with organic ear diseases, abnormal ear structure and symptomatic cerebralinfarction.

  6. Subjects with dementia, neurosyphilis, hypothyroidism and depression.

  7. Subjects has previously participated in other clinical trial within the threemonths.

  8. Subjects with using hearing aids or devices.

  9. Other situations where the researcher thinks it is inappropriate to participate inthis research.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Liuwei Dihuang Pill(placebo )
Phase: 2
Study Start date:
January 24, 2022
Estimated Completion Date:
December 30, 2024

Study 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.

Connect with a study center

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

    Shanghai, Shanghai 200081
    China

    Active - Recruiting

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

    Shanghai, Shanghai 200233
    China

    Active - Recruiting

  • Jiaxing Street Community Health Service Center, Hongkou District, Shanghai

    Shanghai, Shanghai 200086
    China

    Active - Recruiting

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

    Shanghai, Shanghai 201907
    China

    Active - Recruiting

  • Sixth people's Hospital Affiliated to Shanghai Jiaotong University

    Shanghai, Shanghai 200233
    China

    Active - Recruiting

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

    Shanghai, Shanghai 200437
    China

    Active - Recruiting

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

    Shanhai, Shanhai 200233
    China

    Site Not Available

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