Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 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 pre-sarcopenia or sarcopenia over the age of 60
详细描述
75 people that meet the inclusion criteria on screening test are assigned to one of three groups by randomization. They take the medication for four weeks under doubleblind. Two study groups take cetylpyridinium chloride of 1.5mg, 4.5mg daily for four 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, four 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
- •Pre-sarcopenia A. Reduced skeletal muscle mass (appendicular skeletal muscle mass/height2) M < 7.0kg/m2, F < 5.7kg/m2
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 (CPC)
1.5mg CPC will be taken daily for four weeks.
干预措施: Cetylpyridinium Chloride (CPC) (Drug)
4.5mg Cetylpyridinium Chloride (CPC)
4.5mg CPC will be taken daily for four weeks.
干预措施: Cetylpyridinium Chloride (CPC) (Drug)
Control
Placebo will be taken daily for four 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, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
次要结局
- Change from baseline in transforming growth factor β1 (TGF-β1)(baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration)
- Change from baseline in insulin like growth factor 1 (IGF-1)(baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration)
- Change from baseline in Myostatin(baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration)
- Change from baseline in interleukin 1 (IL-1)(baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration)
- Change from baseline in fatty acid binding protein 3 (FABP3)(baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration)
- Change from baseline in monocyte chemoattractant protein 1 (MCP-1)(baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration)
- Change from baseline in Skeletal muscle index(baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration)
- Change from baseline in short physical performance battery (SPPB)(baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration)
- Change from baseline in tumor necrosis factor α (TNF-α)(baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration)
- Change from baseline in Grip strength(baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration)
研究者
Sun Gun Chung
Professor
Seoul National University Hospital