RCT Study of Liuwei Dihuang Pill Preventing and Treating Presbycusis With Shen (Kidney)-Yin Deficiency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Change in PB-Max after 48 weeks of treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a current diagnosis of presbyacusis with symmetrical hearing loss, defined as 15-dB or less difference in pure tone average between ears at 0.5, 1, 2 and 4kHz. The average hearing threshold loss level is mild or moderate (20 ≤ average hearing threshold < 50 dBHL).
- •Adult aged 65-75 years inclusive.
- •Maximum speech recognition rate in quiet environment is equal to or over 60% with ability to communicate well.
- •Subjects have no cognitive impairment with CDR score =
- •Subjects must have a current diagnosis of Shen (Kidney)-Yin Deficiency.
- •Subjects have read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.
排除标准
- •Subjects with sudden hearing loss or pure tone hearing fluctuation within the three months.
- •Subjects with a history of serious mental illness.
- •Subjects with severe cardiac insufficiency, malignant tumor or other serious systemic diseases.
- •Subjects with conductive deafness, congenital deafness, hereditary deafness, inner ear immune and autoimmune inner ear diseases, auditory neuropathy, toxic deafness and noise deafness.
- •Subjects with organic ear diseases, abnormal ear structure and symptomatic cerebral infarction.
- •Subjects with dementia, neurosyphilis, hypothyroidism and depression.
- •Subjects has previously participated in other clinical trial within the three months.
- •Subjects with using hearing aids or devices.
- •Other situations where the researcher thinks it is inappropriate to participate in this research.
研究组 & 干预措施
LDP group
Liuwei Dihuang Pill (LDP）marketed product in China donated by pharmaceutical company.
干预措施: Liuwei Dihuang Pill (marketed product in China) (Drug)
placebo group
Same smell, color and shape as Liuwei Dihuang Pill (LDP）without herbs in capsules.
干预措施: Liuwei Dihuang Pill（placebo ） (Drug)
结局指标
主要结局
Change in PB-Max after 48 weeks of treatment
时间窗: 48 weeks
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.
次要结局
- Change in Speech recognition threshold (SRT) after 24 weeks and 48 weeks of treatment(24 weeks，48 weeks)
- Change in Pure Tone Average (PTA) after 24 weeks and 48 weeks of treatment(24 weeks，48 weeks)
- Change in Shen (Kidney)-Yin Deficiency Syndrome Questionnaire after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment(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(12 weeks，24 weeks，36 weeks，48 weeks)
- Change in Mini-mental State Examination (MMSE) after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment(12 weeks，24 weeks，36 weeks，48 weeks)
研究者
Jianrong Shi
Professor&Vice-Principal
Shanghai Jiao Tong University School of Medicine