Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05125081
Study type Interventional
Source Shanghai Jiao Tong University School of Medicine
Contact Jianrong Shi, Doctor
Phone 86-21-63846590
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date December 1, 2021
Completion date October 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT04601909 - FX-322 in Adults With Age-Related Sensorineural Hearing Loss Phase 1
Recruiting NCT04030299 - Longitudinal Outcomes of Hearing Aids N/A
Enrolling by invitation NCT02729402 - Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults N/A
Completed NCT01788423 - Evaluating Hearing Aid Service Delivery Models N/A
Completed NCT00371449 - Predicting Success With Hearing Aids N/A
Recruiting NCT04360109 - Study of the Association Between Presbycusis With the Incidence of Frailty
Completed NCT00488007 - Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids N/A
Enrolling by invitation NCT03101722 - Effects of Huperzine A on Presbycusis(Δ,kHz, dB,MMSE, AD) N/A
Recruiting NCT04923087 - Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)
Completed NCT02448706 - Variability In Hearing Aid Outcomes In Older Adults N/A
Completed NCT01950013 - At-home Auditory Training Clinical Trial N/A
Completed NCT04200664 - Audiovestibular Function in Infratentorial Superficial Siderosis
Recruiting NCT03579563 - Cost-effective Hearing Aid Delivery Models N/A
Completed NCT03638323 - Age-related Hearing Loss and Lexical Disorders
Completed NCT01732289 - Genetic Study of Age Related Hearing Loss Phase 0
Recruiting NCT03720964 - Mitochondrial Genetics of Presbycusis
Completed NCT02147847 - Computer-Based Auditory Rehabilitation N/A