NCT05125081

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

RCT Study of Liuwei Dihuang Pill Preventing and Treating Presbycusis With Shen (Kidney)-Yin Deficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Presbycusis
• Age-related Hearing Loss
• Hearing Disorders and Deafness

Interventions

Type	Name	Description
DRUG	Liuwei Dihuang Pill (marketed product in China)	LDP group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo group and LDP group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the LDP group and placebo group at a ratio of 1:1. The drug was administered for 48 weeks, 3 times a day, 8 pills each time.
DRUG	Liuwei Dihuang Pill（placebo ）	LDP group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo group and LDP group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the LDP group and placebo group at a ratio of 1:1. The drug was administered for 48 weeks, 3 times a day, 8 pills each time.

Timeline

• Start date: 2022-01-25
• Primary completion: 2024-08-07
• Completion: 2024-12-25
• First posted: 2021-11-18
• Last updated: 2026-01-07

Locations

6 sites across 1 country: China