NCT00471055

Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 0.0125% of Capsaicin to Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether capsaicin gel is effective in treating mild to moderate degrees of osteoarthritis of the knee in the elderly patient compared with placebo gel.

Detailed description

Osteoarthritis (OA) is the most common form of arthritis in the population. It is characterized pathologically by both focal loss of articular cartilage and marginal and central new bone formation. OA of knee, the principal large joint to be affected, results in disabling knee symptoms in an estimated 10% of people older than 55 years, a quarter of whom are severely disabled. The risk of disability attributable to knee OA alone is as great as that due to cardiac disease and greater than that due to any other medical disorder in the elderly. A recent World Health Organization report on the global burden of disease indicates that knee OA is likely to become the fourth most important global cause of disability in women and the eighth most important in men. Knee OA is associated with symptoms of pain and functional disability. Physical disability arising from pain and loss of functional capacity reduces quality of life and increases the risk of further morbidity and mortality. Current treatments aim at alleviating these symptoms of mild to moderate OA by several different methods: non-pharmacological treatment (for example education, exercise, lifestyle changes) or pharmacological treatments(for example paracetamol, NSAIDs and Capsaicin gel topical treatments). Current evidence to support the various treatments in current use, however, is very variable. Capsaicin, the active principle of hot chili pepper, is thought to selectively stimulate unmyelinated C fibre afferent neurons and cause the release of substance P. Prolonged application of capsaicin reversibly depletes stores of substance P, and possibly other neurotransmitters, from sensory nerve endings. This reduces or abolishes the transmission of painful stimuli from the peripheral nerve fibres to the higher centres.There were many study on Capsaicin gel to confirm the effectiveness of capsaicin gel in many dosages. However, there has been no efficacy study on the capsaicin 0.0125% of the Thai produce "Capsika gel " before, therefore, this study is proposed.

Conditions

• Osteoarthritis, Knee Joint
• Capsicum

Interventions

Type	Name	Description
DRUG	0.0125% Capsaicin gel "CAPSIKA gel"
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-10-01
• Completion: 2007-12-01
• First posted: 2007-05-09
• Last updated: 2008-07-09

Locations

1 site across 1 country: Thailand