Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia: An Exploratory Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Change from baseline in procollagen type III N-terminal peptide
研究概览
简要总结
This study is to assess the impact on the prevention of sarcopenia after taking cetylpyridinium chloride targeting the patients of presarcopenia over the age of 60.
详细描述
65 people that meet the inclusion criteria on screening test are assigned to one of five groups by randomization. They take the medication for two weeks under double-blind. Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks. Control group takes the placebo for the same period. The main outcome variables are measured and compared respectively in baseline, immediately after dosing end and two weeks after the end of administration. Finally cetylpyridinium chloride is verified whether it has a preventive effect on sarcopenia and set an appropriate dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presarcopenia A. Reduced skeletal muscle mass (ASM/height2) M < 7.0kg/m2, F < 5.7kg/m2 B. Normal grip strength M ≥ 26kg, F ≥ 18kg C. Normal physical performance Gait speed > 0.8m/s
- •Community dwelling
排除标准
- •History of stroke or spinal cord injury
- •Artificial joint
- •Acute disease or unstable chronic disease
- •Phenylketonuria
- •History of myocardiac infarction
- •Allergic contact dermatitis
- •History of drug/alcohol addiction, habitual smoker
研究组 & 干预措施
1.5mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 1.5mg will be taken daily for two weeks.
干预措施: cetylpyridinium chloride (Drug)
3mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 3mg will be taken daily for two weeks.
干预措施: cetylpyridinium chloride (Drug)
4.5mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 4.5mg will be taken daily for two weeks.
干预措施: cetylpyridinium chloride (Drug)
6mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 6mg will be taken daily for two weeks.
干预措施: cetylpyridinium chloride (Drug)
Control
Placebo will be taken daily for two weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in procollagen type III N-terminal peptide
时间窗: baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in TNF-α
时间窗: baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in IL-6
时间窗: baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in myostatin
时间窗: baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in urinary creatinine
时间窗: baseline, immediately after dosing end, two weeks after the end of administration
次要结局
- Change from baseline in CRP(baseline, immediately after dosing end, two weeks after the end of administration)
- Change from baseline in Hemoblobin(baseline, immediately after dosing end, two weeks after the end of administration)
- Change from baseline in Albumin(baseline, immediately after dosing end, two weeks after the end of administration)
- Change from baseline in Vitamin D(baseline, immediately after dosing end, two weeks after the end of administration)
研究者
Sun Gun Chung
Professor
Seoul National University Hospital