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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Age-related Hearing Loss; Presbycusis; Hearing Disorders and Deafness

Treatments: Drug: Liuwei Dihuang Pill（placebo ）; Drug: Liuwei Dihuang Pill (marketed product in China)

Study type: Interventional

Funder types: Other

Identifiers

NCT05125081

RLDP-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 65 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

LDP group

Experimental group

Description:

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

Treatment:

Drug: Liuwei Dihuang Pill (marketed product in China)

placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Liuwei Dihuang Pill（placebo ）