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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.5mg Cetylpyridinium Chloride | Experimental | Cetylpyridinium chloride of 1.5mg will be taken daily for two weeks. |
|
| 3mg Cetylpyridinium Chloride | Experimental | Cetylpyridinium chloride of 3mg will be taken daily for two weeks. |
|
| 4.5mg Cetylpyridinium Chloride | Experimental | Cetylpyridinium chloride of 4.5mg will be taken daily for two weeks. |
|
| 6mg Cetylpyridinium Chloride | Experimental | Cetylpyridinium chloride of 6mg will be taken daily for two weeks. |
|
| Control | Placebo Comparator | Placebo will be taken daily for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetylpyridinium chloride | Drug | Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in procollagen type III N-terminal peptide | baseline, immediately after dosing end, two weeks after the end of administration | |
| Change from baseline in myostatin | baseline, immediately after dosing end, two weeks after the end of administration | |
| Change from baseline in TNF-α | baseline, immediately after dosing end, two weeks after the end of administration | |
| Change from baseline in IL-6 | baseline, immediately after dosing end, two weeks after the end of administration | |
| Change from baseline in urinary creatinine | baseline, immediately after dosing end, two weeks after the end of administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in CRP | baseline, immediately after dosing end, two weeks after the end of administration | |
| Change from baseline in Hemoblobin | baseline, immediately after dosing end, two weeks after the end of administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Gun Chung, MD, PhD | Seoul National University College of Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19657557 | Background | Pahor M, Manini T, Cesari M. Sarcopenia: clinical evaluation, biological markers and other evaluation tools. J Nutr Health Aging. 2009 Oct;13(8):724-8. doi: 10.1007/s12603-009-0204-9. | |
| 12028177 | Background | Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002594 | Cetylpyridinium |
| ID | Term |
|---|---|
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo | Drug | Control group takes the placebo for the same period. |
|
| Change from baseline in Albumin | baseline, immediately after dosing end, two weeks after the end of administration |
| Change from baseline in Vitamin D | baseline, immediately after dosing end, two weeks after the end of administration |
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |