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

NCT05125081 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Shanghai University of Traditional Chinese Medicine

    collaborator OTHER

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Jianrong Shi, Doctor · Shanghai Jiao Tong University School of Medicine

  • Jianning Zhang, Doctor · Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

  • Ping Huang, Doctor · Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

  • Hongsheng Tan, Doctor · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2024-08-07
Completion
2024-12-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05125081 on ClinicalTrials.gov