Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Khon Kaen University Bangkok Laboratories and Cosmetics |
---|---|
Information provided by: | Khon Kaen University |
ClinicalTrials.gov Identifier: | NCT00471055 |
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.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis, Knee Joint Capsicum |
Drug: 0.0125% Capsaicin gel "CAPSIKA gel" Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 0.0125% of Capsaicin to Placebo |
Enrollment: | 100 |
Study Start Date: | June 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Capsaicin and placebo controlled,Cross-over design study
|
Drug: 0.0125% Capsaicin gel "CAPSIKA gel" |
B: Placebo Comparator
Capsaicin and placebo controlled,Cross-over design study
|
Drug: Placebo
Placebo
|
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.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects eligible for enrollment in the study must meet all of the following criteria:
Exclusion Criteria:
Subjects with any of the following criteria must not be enrolled in the study:
Treatment with other drugs potentially affecting bone or cartilage metabolism as described below:
Thailand, Khon Kaen | |
Weerachai Kosuwon | |
Khon kaen University, Khon Kaen, Thailand, 40002 |
Principal Investigator: | weerachai Kosuwon, M.D | Department of Orthopedics, Faculty of Medicine, Khon kaen University |
Study ID Numbers: | Khonkaen-ortho 1 |
Study First Received: | May 8, 2007 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00471055 |
Health Authority: | Thailand: Khon Kaen University Ethics Committee for Human Research |
osteoarthritis knee capsaicin gel capsicum |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Rheumatic Diseases Capsaicin |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Antipruritics |
Peripheral Nervous System Agents Dermatologic Agents Pharmacologic Actions |