Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

Sarcopenia Clinical Trial

Official title:

Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia: An Exploratory Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297997
• Other study ID #: SNUHRM
• Status: Completed
• Phase: Early Phase 1
• Start date: November 13, 2014
• Est. completion date: November 2015

Study information

• Verified date: March 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 presarcopenia over the age of 60.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Drug:
• cetylpyridinium chloride
Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
• Placebo
Control group takes the placebo for the same period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

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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, immediately after dosing end, two weeks after the end of administration
Primary	Change from baseline in myostatin		baseline, immediately after dosing end, two weeks after the end of administration
Primary	Change from baseline in TNF-a		baseline, immediately after dosing end, two weeks after the end of administration
Primary	Change from baseline in IL-6		baseline, immediately after dosing end, two weeks after the end of administration
Primary	Change from baseline in urinary creatinine		baseline, immediately after dosing end, two weeks after the end of administration
Secondary	Change from baseline in CRP		baseline, immediately after dosing end, two weeks after the end of administration
Secondary	Change from baseline in Hemoblobin		baseline, immediately after dosing end, two weeks after the end of administration
Secondary	Change from baseline in Albumin		baseline, immediately after dosing end, two weeks after the end of administration
Secondary	Change from baseline in Vitamin D		baseline, immediately after dosing end, two weeks after the end of administration