Clinical Trial: Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia

Brief Summary: 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

Detailed Summary: 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.
Sponsor: Seoul National University Hospital

Current Primary Outcome: Change from baseline in procollagen type III N-terminal peptide [ Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in IGF-1 [ Time Frame: 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 TGF-β1 [ Time Frame: 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 [ Time Frame: 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 TNF-α [ Time Frame: 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 IL-1 [ Time Frame: 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 FABP3 [ Time Frame: 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 MCP-1 [ Time Frame: 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 [ Time Frame: 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 SPPB [ Time Frame: 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 [ Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration ]


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: October 12, 2015
Date Started: October 2015
Date Completion: August 2016
Last Updated: October 13, 2015
Last Verified: October 2015