Knee osteoarthritis Mild to moderate knee pain Knee osteoarthritis Topical drugs Thai medicinal plants Diclofenac gel
Conditions
Interventions
apply approximately 2 g per the affected knee,
for 4 weeks (without massage),apply approximately 2 g per the affected knee,
Active Comparator Drug,Experimental Drug
Diclofenac gel,Thai medicinal plant cream
Sponsors
Department of Pharmacology, Faculty of Medicine, Chiang Mai University
Asian Phytoceuticals Public Company Limited (APCO)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: a) An out-patient, aged ≥ 45 years; b) Unilateral or bilateral knee OA according to the criteria of ACR: knee pain, radiographic osteophytes, and at least 1 of the following 3 items: age > 50 years, morning stiffness not more than 30 minutes in duration, or crepitus on motion. The symptoms must be present for at least 3 months; c) VAS of knee pain between 35-75 point (out of 100) after stopping using their usual analgesic or NSAIDs for, at least, 7 days; d) Able to walk; and e) must sign the written consent forms to participate in the study.
Exclusion criteria
Exclusion criteria: a) Underlying inflammatory arthropathy, such as rheumatoid arthritis and gout; b) Hyperuricemia (uric acid > 9 mg/dL); c) Plan to undergo surgery in near future; d) Recent injury in the knee affected by OA; e) History of intra-articular corticosteroid injection within the last 3 months; f) Hypersensitivity to NSAIDs or herbs used in this study; g) Use of other NSAIDs or analgesic drugs; h) Acute OA attack (inflammation, edema, redness, warmth); i) Knee joint effusion; j) Continuing use of symptomatic slow-acting drugs for OA (SYSDOA) [e.g., glucosamine sulphate, chondroitin sulphate, diacerein, and hyaluronan] for less than 4 months or stop using these drugs for less than 6 months; k) Concomitant skin disease at the application site; l) Use of another topical product at the application site; m) Pregnancy or lactation; n) Malignant tumor; or o) Clinically significant abnormalities in blood chemistry and hematology:  Hemoglobin < 9 g/dL  White blood cells < 4,000 per cu. mm.  Platelets < 100,000 per cu. mm.  Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase more than 2 times of the upper limit of normal  Estimated glomerular filtration rate < 45 mL/min per 1.73 m2 as of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responders at 4 weeks after starting the intervention Visual analog scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Knee symptoms and function at 0, 2 and 4 weeks after starting the intervention The knee injury and Osteoarthritis Outcome Score ,Stiffness at 0, 2 and 4 weeks after starting the intervention Visual analog scale,Function at 0,2 and 4 weeks after starting the intervention Time for climbing up 10 steps,Function at 0,2 and 4 weeks after starting the intervention Time up and go,Adverse events at 2 and 4 weeks after starting the intervention Non-directive questioning and diary card | — |
Contacts
Public ContactNutthiya Hanprasertpong
Faculty of Medicine, Chiang Mai University
Outcome results
None listed