Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy
NCT ID: NCT02297997
Last Updated: 2021-03-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
EARLY_PHASE1
Total Enrollment
65 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-11-13
Study Completion Date
2015-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Sarcopenia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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1.5mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 1.5mg will be taken daily for two weeks.
Group Type
EXPERIMENTAL
cetylpyridinium chloride
Intervention Type
DRUG
Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
3mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 3mg will be taken daily for two weeks.
Group Type
EXPERIMENTAL
cetylpyridinium chloride
Intervention Type
DRUG
Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
4.5mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 4.5mg will be taken daily for two weeks.
Group Type
EXPERIMENTAL
cetylpyridinium chloride
Intervention Type
DRUG
Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
6mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 6mg will be taken daily for two weeks.
Group Type
EXPERIMENTAL
cetylpyridinium chloride
Intervention Type
DRUG
Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
Control
Placebo will be taken daily for two weeks.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Control group takes the placebo for the same period.
Interventions
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cetylpyridinium chloride
Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
Intervention Type
DRUG
Placebo
Control group takes the placebo for the same period.
Intervention Type
DRUG
Other Intervention Names
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CEGATON Troche
Eligibility Criteria
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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
* 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
* Artificial joint
* Acute disease or unstable chronic disease
* Phenylketonuria
* History of myocardiac infarction
* Allergic contact dermatitis
* History of drug/alcohol addiction, habitual smoker
Minimum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Seoul National University Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Sun Gun Chung
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Sun Gun Chung, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University College of Medicine
References
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Other Identifiers
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SNUHRM
Identifier Type: -
Identifier Source: org_study_id
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