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

• Status: Not yet recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborator: Shanghai University of Traditional Chinese Medicine

Criteria

Inclusion Criteria:

1. Adult aged 65-75 years inclusive.

2. Subjects must have a current diagnosis of age-related sensorineural symmetric hearing loss in the range of 20-50 dB by standard audiometric measures. The tympanic diagram of binaural acoustic immittance is type A. The speech recognition rate decreased significantly.

3. Maximum speech recognition rate in quiet environment is equal to or over 60% with ability to communicate well.

4. Subjects have read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.

5. Subjects have no cognitive impairment with MMSE score ≥ 21 .

6. Subjects must have a current diagnosis of Shen (Kidney)-Yin Deficiency.

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 infectious 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.