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A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis - Trial NCT06021665

Access comprehensive clinical trial information for NCT06021665 through Pure Global AI's free database. This phase not specified trial is sponsored by MYOS Corp and is currently Recruitment Completed. The study focuses on Osteoarthritis. Target enrollment is 40 participants.

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NCT06021665
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Trial Details
ClinicalTrials.gov โ€ข NCT06021665
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A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis

Study Focus

Osteoarthritis

Fortetropin supplement

Interventional

other

Sponsor & Location

MYOS Corp

Santa Monica, United States of America

Timeline & Enrollment

N/A

Jun 19, 2023

Nov 01, 2023

40 participants

Primary Outcome

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scoring. [Baseline to Week 12],Change in Numeric Pain Rating Scale (NPRS). [Baseline to Week 12],Changes in muscle mass perceived by participants. [Baseline to Week 12]

Summary

This is a hybrid, double-blind, randomized, placebo-controlled clinical trial that will last
 12 weeks. Participants will be randomized into either the intervention product or control
 group and will consume the test product or control daily. Participants will complete
 study-specific and validated questionnaires at Baseline, Week 6, and Week 12, as well as
 blood biomarker testing for a lipid panel and high-sensitivity C-reactive protein (hs-CRP) at
 Baseline and Week 12.
 
 Osteoarthritis-like symptoms, such as joint pain, inflammation, and reduced mobility will be
 evaluated at baseline and at each check-in. Likert scale responses will be examined from
 baseline to each check-in. Participant responses on product feedback will be presented as %
 scores. Two validated questionnaires, Western Ontario and McMaster Universities Arthritis
 Index (WOMAC) and the Numeric Pain Rating Scale (NPRS) will also be completed at the
 questionnaire time points. A full lipid panel and hs-CRP measurement will be completed via
 in-person blood draws.

ICD-10 Classifications

Other hypertrophic osteoarthropathy
Other specified osteochondropathies
Polyarthritis, unspecified
Other osteochondropathies
Osteochondritis dissecans

Data Source

ClinicalTrials.gov

NCT06021665

Non-Device Trial