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

Sarcopenia Clinical Trial

— CPC2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575235
• Other study ID #: SNUHRM-CPC2
• Status: Completed
• Phase: Early Phase 1
• Start date: October 1, 2015
• Est. completion date: July 1, 2016

Study information

• Verified date: September 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Pre-sarcopenia A. Reduced skeletal muscle mass (appendicular skeletal muscle mass/height2) M < 7.0kg/m2, F < 5.7kg/m2

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Drug:
• Cetylpyridinium Chloride (CPC)
Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks.
• placebo
Control group takes the placebo for the same period.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in procollagen type III N-terminal peptide		baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Secondary	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
Secondary	Change from baseline in transforming growth factor ß1 (TGF-ß1)		baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Secondary	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
Secondary	Change from baseline in tumor necrosis factor a (TNF-a)		baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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