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

NCT02156440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-06-05

No results posted yet for this study

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.

Conditions

  • Osteoarthritis of the Knee

Interventions

DIETARY_SUPPLEMENT

SierraSil Joint Formula 14

667 mg SierraSil® hydrothermal mineral complex

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • SierraSil Health Inc

    collaborator INDUSTRY

  • KGK Science Inc.

    lead INDUSTRY

Principal Investigators

  • Dale Wilson, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02156440 on ClinicalTrials.gov