The Effects of Resveratrol on the Complications of Patients With 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
- 36
- 试验地点
- 1
- 主要终点
- Pure tone audiometry (PTA)
研究概览
简要总结
Participants'll include 140 adult patients with CKD and receiving hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo medication therapy; resveratrol group will receive oral resveratrol (100 mg per day). All participants will receive either treatment for 1year, and receive examinations of pure tone audiometry, speech reception thresholds, and speech discrimination score.
详细描述
Patients with chronic kidney disease (CKD) often suffered from hearing impairment, vertigo/dizziness, cognitive degeneration, cardiovascular diseases. In addition, compared to patients without CKD, the longevity of patients with CKD was also shorter. The mechanism underlying the complications of CKD were very complicated, but were generally associated with uremic toxins, tissue hypoxia, free radicals damages. Meanwhile, some co-morbidities, for example, diabetes mellitus, hypertension, atherosclerosis, would also worsen the complications of CKD. However, only limited methods were reported to have beneficial effects on renal function and its complications. For, example, controlling co-morbidities of CKD, avoiding nephrotoxic substances, and dialysis.
Resveratrol, it could prevent deterioration of cardiovascular diseases and cancer progression. But, the beneficial effects of resveratrol on hearing impairment, tinnitus, vertigo/dizziness, cognitive degeneration, cancer development, death in patients with CKD were also unclear.
This study aimed to investigate the beneficial effects of resveratrol on hearing impairment in patients with CKD by a prospective, randomized, double-blinded clinical trial design.
Participants'll include 140 adult patients with CKD and receiving hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo medication therapy; resveratrol group will receive oral resveratrol (100 mg per day). All patients will receive either treatment for 1year, and receive examinations of pure tone audiometry, speech reception thresholds, and speech discrimination score.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic kidney disease (CKD) and routine hemodialysis
- •Age limits 40~69 years old
- •Normal hearing or symmetrical sensorineural hearing loss, all ears frequency differences are less than 15 dB
排除标准
- •Life can not take care of themselves or the bed of a patient
- •Acceptance of peritoneal dialysis patients
- •Moderate hearing loss (pure tone average hearing threshold greater than 50 dB)
- •Moderate or severe cognitive impairment (Mini-Mental State Examination score less than 21 points)
- •The details of the study can not understand or can not fit the patient examination.
- •A history of alcohol or drug abuse
- •The high ambient noise exposure history
- •Poor guide backbone pure tone hearing thresholds greater than 10 decibels, trying to listen to 4 kilohertz air conduction threshold is greater than 8 kilohertz air conduction threshold value of 20 dB
- •Before the age of 30 have hearing loss
- •Had a stroke, myocardial infarction, a history of cancer
- •Pregnant woman
研究组 & 干预措施
control
Control group will receive placebo medication therapy
干预措施: Placebo (Dietary Supplement)
test group
resveratrol group will receive oral resveratrol (100 mg per day)
干预措施: resveratrol (Dietary Supplement)
结局指标
主要结局
Pure tone audiometry (PTA)
时间窗: one year
pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.
次要结局
- Speech Audiometry(one year)