Phase
Condition
Deafness
Aging
Hearing Impairment
Treatment
Liuwei Dihuang Pill(placebo )
Liuwei Dihuang Pill (marketed product in China)
Clinical Study ID
Ages 65-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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).
Adult aged 65-75 years inclusive.
Maximum speech recognition rate in quiet environment is equal to or over 60% withability 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 allquestions have been answered and prior to any study-mandated procedure.
Exclusion
Exclusion Criteria:
Subjects with sudden hearing loss or pure tone hearing fluctuation within the threemonths.
Subjects with a history of serious mental illness.
Subjects with severe cardiac insufficiency, malignant tumor or other serioussystemic diseases.
Subjects with conductive deafness, congenital deafness, hereditary deafness, innerear immune and autoimmune inner ear diseases, auditory neuropathy, toxic deafnessand noise deafness.
Subjects with organic ear diseases, abnormal ear structure and symptomatic cerebralinfarction.
Subjects with dementia, neurosyphilis, hypothyroidism and depression.
Subjects has previously participated in other clinical trial within the threemonths.
Subjects with using hearing aids or devices.
Other situations where the researcher thinks it is inappropriate to participate inthis research.
Study Design
Study Description
Connect with a study center
Community Health Service Center of North Sichuan Road, Hongkou District, Shanghai
Shanghai, Shanghai 200081
ChinaActive - Recruiting
Community Health Service Center of Tianlin Street, Xuhui District, Shanghai
Shanghai, Shanghai 200233
ChinaActive - Recruiting
Jiaxing Street Community Health Service Center, Hongkou District, Shanghai
Shanghai, Shanghai 200086
ChinaActive - Recruiting
Juquan New Town Community Health Service Center, Gucun Town, Baoshan District, Shanghai
Shanghai, Shanghai 201907
ChinaActive - Recruiting
Sixth people's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai 200233
ChinaActive - Recruiting
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai 200437
ChinaActive - Recruiting
Community Health Service Center of Tianlin Street, Xuhui District, Shanghai
Shanhai, Shanhai 200233
ChinaSite Not Available
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