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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2024-12-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Presbycusis Age-related Hearing Loss Hearing Disorders and Deafness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LDP group

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

Group Type EXPERIMENTAL

Liuwei Dihuang Pill (marketed product in China)

Intervention Type 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.

placebo group

Same smell, color and shape as Liuwei Dihuang Pill (LDP）without herbs in capsules.

Group Type PLACEBO_COMPARATOR

Liuwei Dihuang Pill（placebo ）

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Liu Wei Di Huang Pill placebo group

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jianrong Shi

Professor&Vice-Principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianrong Shi, Doctor

Role: STUDY_DIRECTOR

Shanghai Jiao Tong University School of Medicine

Jianning Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Ping Huang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Hongsheng Tan, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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