Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

Seoul National University

Status and phase: Completed; Early Phase 1

Conditions: Sarcopenia

Treatments: Drug: Placebo; Drug: cetylpyridinium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02297997

SNUHRM

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 presarcopenia over the age of 60.

Full description

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.

Enrollment: 65 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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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65 participants in 5 patient groups, including a placebo group

1.5mg Cetylpyridinium Chloride

Experimental group

Description:

Cetylpyridinium chloride of 1.5mg will be taken daily for two weeks.

Treatment:

Drug: cetylpyridinium chloride

3mg Cetylpyridinium Chloride

Experimental group

Description:

Cetylpyridinium chloride of 3mg will be taken daily for two weeks.

Treatment:

Drug: cetylpyridinium chloride

4.5mg Cetylpyridinium Chloride

Experimental group

Description:

Cetylpyridinium chloride of 4.5mg will be taken daily for two weeks.

Treatment:

Drug: cetylpyridinium chloride

6mg Cetylpyridinium Chloride

Experimental group

Description:

Cetylpyridinium chloride of 6mg will be taken daily for two weeks.

Treatment:

Drug: cetylpyridinium chloride

Control

Placebo Comparator group

Description:

Placebo will be taken daily for two weeks.

Treatment:

Drug: Placebo