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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
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.
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.
Community Health Service Center of North Sichuan Road, Hongkou District, Shanghai
Shanghai, Shanghai Municipality, China
Jiaxing Street Community Health Service Center, Hongkou District, Shanghai
Shanghai, Shanghai Municipality, China
Community Health Service Center of Tianlin Street, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, China
Change in PB-Max after 48 weeks of treatment
To compare the change in PB-Max using the Word Recognition in Quiet test measured with Consonant-Nucleus-Consonant (CNC) word lists from baseline (week 1 to week 48) between LDP and placebo.
Time frame: 48 weeks
Change in Speech recognition threshold (SRT) after 24 weeks and 48 weeks of treatment
To compare the change in Speech recognition threshold (SRT) using the Word Recognition in Quiet test measured with Consonant-Nucleus-Consonant (CNC) word lists from baseline (week 1 to week 24,week 48) between LDP and placebo.
Time frame: 24 weeks,48 weeks
Change in Pure Tone Average (PTA) after 24 weeks and 48 weeks of treatment
To compare the change in Pure Tone Average (PTA) using the Air conduction audiometry for hearing at certain range (Hz) from baseline (week 1 to week 24,week 48) between LDP and placebo.
Time frame: 24 weeks,48 weeks
Change in Shen (Kidney)-Yin Deficiency Syndrome Questionnaire after 12 weeks,24 weeks,36 weeks and 48 weeks of treatment
To compare the change in Shen (Kidney)-Yin Deficiency Syndrome Questionnaire using Face to face Interview for the scores from baseline (week 1 to week 12,week 24,week 36 and week 48) between LDP and placebo (range, 0 \[best\] to 100 \[worst\]).
Time frame: 12 weeks,24 weeks,36 weeks,48 weeks
Change in Tinnitus Handicap Inventory(THI)after 12 weeks,24 weeks,36 weeks and 48 weeks of treatment
To compare the change in Tinnitus Handicap Inventory(THI)using Face to face Interview for the scores from baseline (week 1 to week 12,week 24,week 36 and week 48) between LDP and placebo (range, 0 \[best\] to 100 \[worst\]).
Time frame: 12 weeks,24 weeks,36 weeks,48 weeks
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Sixth people's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Juquan New Town Community Health Service Center, Gucun Town, Baoshan District, Shanghai
Shanghai, Shanghai Municipality, China
Change in Mini-mental State Examination (MMSE) after 12 weeks,24 weeks,36 weeks and 48 weeks of treatment
To compare the change in Mini-mental State Examination (MMSE) using Face to face Interview for the scores from baseline (week 1 to week 12,week 24,week 36 and week 48) between LDP and placebo (range, 0 \[worst\] to 100 \[best\]).
Time frame: 12 weeks,24 weeks,36 weeks,48 weeks