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Cross-over Study of the Efficacy and Safety of SierraSil Joint Formula 14 in Osteoarthritis of the Knee — 11SOHS  

Osteoarthritis of the Knee Clinical Trial

Official title:
A Double Blind, Placebo Controlled Cross Over Study to Explore the Efficacy of SierraSil® Joint Formula 14™ in Adults With Osteoarthritis of the Knee

Clinical Trial Summary

Osteoarthritis (OA) affects approximately 10% of people older than 60 years, and compromises the quality of life of more than 21 million North Americans. Studies on the use of complimentary and alternative medicines have reported that OA patients in the US are among the highest users of CAM. Previous studies on a unique natural mineral product SierraSil® demonstrated an improvement in joint health and function in subjects with mild to moderate OA of the knee. Extracts of Sierrasil® are reported to reduce cartilage degradation in response to IL-8 and nitric oxide production suggesting an ability to suppress IL-8 mediated events in human cartilage. The primary objective is to assess the efficacy of SeirraSil Joint Formula versus placebo on the symptoms of osteoarthritis as assessed by WOMAC™ Osteoarthritis Index Pain subscale in subjects with osteoarthritis of the knee.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02156440
Study type Interventional
Source KGK Synergize Inc.
Contact
Status Completed
Phase Phase 2
Start date September 2011
Completion date April 2012
View Details
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