Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia (CPC2)

Seoul National University

Status and phase: Completed; Early Phase 1

Conditions: Sarcopenia

Treatments: Drug: Cetylpyridinium Chloride (CPC); Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02575235

SNUHRM-CPC2

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups, including a placebo group

1.5mg Cetylpyridinium Chloride (CPC)

Experimental group

Description:

1.5mg CPC will be taken daily for four weeks.

Treatment:

Drug: Cetylpyridinium Chloride (CPC)

4.5mg Cetylpyridinium Chloride (CPC)

Experimental group

Description:

4.5mg CPC will be taken daily for four weeks.

Treatment:

Drug: Cetylpyridinium Chloride (CPC)

Control

Placebo Comparator group

Description:

Placebo will be taken daily for four weeks

Treatment:

Drug: placebo