The Beneficial Effects of Pomegranate on Hearing of Patients Without Hemodialysis: A Prospective, Randomized, Double-blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pure tone audiometry (PTA)
研究概览
简要总结
Pomegranate has anti-oxidative capacity. It might reduce symptoms of Alzheimer's disease, Drug-induced hepatitis, and might prevent deterioration of cardiovascular diseases and cancer progression. But, the beneficial effects of pomegranate on hearing impairment was still unclear.
This study aimed to investigate the beneficial effects of pomegranate on hearing impairment by a prospective, randomized, double-blinded clinical trial design. The investigators'll include 120 elderly patients without hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo treatment; pomegranate group will receive oral pomegranate (500 mg, twice per day).
All patients received the above treatment for 9 months, and underwent pure tone audiometry and word discrimination scores before the start of the clinical trial and at the end of the treatment (9th month).
详细描述
Pomegranate has anti-oxidative capacity. It might reduce symptoms of Alzheimer's disease, Drug-induced hepatitis, and might prevent deterioration of cardiovascular diseases and cancer progression. But, the beneficial effects of pomegranate on hearing impairment was still unclear.
This study aimed to investigate the beneficial effects of pomegranate on hearing impairment by a prospective, randomized, double-blinded clinical trial design. The investigators'll include 120 elderly patients without hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo treatment; pomegranate group will receive oral pomegranate (500 mg, twice per day).
All patients received the above treatment for 9 months, and underwent pure tone audiometry and word discrimination scores before the start of the clinical trial and at the end of the treatment (9th month).
<background> Age-related hearing impairment (ARHI) was very common in the elderly. Hearing deteriorated not only due to problems with the peripheral hearing organs, but also because of degeneration of the central auditory system. In general, peripheral hearing deteriorates more quickly and severely in male subjects than in female subjects, more severely at higher than low frequencies, and more quickly in the central auditory system than the peripheral hearing organs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50 to 80 years old.
- •non-renal dialysis patients.
排除标准
- •Life can not take care of themselves or the bed of a patient.
- •dialysis patients.
- •Patients who can not understand the details of this study or are unable to cooperate with the examination.
- •history of alcohol or drug abuse.
- •history of high environmental noise exposure.
- •The pure tone hearing threshold is greater than 10 decibel (dB), and the audiogram 4 kilohertz (kHz) air conduction threshold is greater than 8 kilohertz (kHz) air threshold value of 20 decibel (dB).
研究组 & 干预措施
control group
Control group will receive placebo medication therapy
干预措施: Placebo (Dietary Supplement)
test group
pomegranate group will receive oral pomegranate (500 mg, twice per day)
干预措施: Pomegranate (Dietary Supplement)
结局指标
主要结局
Pure tone audiometry (PTA)
时间窗: 9 months
pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.
次要结局
- speech discrimination score (SDS)(9 months)
- speech reception threshold (SRT)(9 months)