CompletedPhase 2

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

China120 participantsStarted 2022-01-25

Plain-language 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.

Age range65 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Change in PB-Max after 48 weeks of treatment

Timeframe: 48 weeks

NCT IDNCT05125081

SponsorShanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-07

Who can participate

Age range65 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.