Comparative efficacy of 5-Loxin® and its improved composition (5-Loxin®BSO) in the treatment of osteoarthritis of knee: a randomised, double-blind placebo-controlled clinical study

INTERVENTION: 60 subjects randomised into 3 groups (n = 20): 1. 5‐Loxin® (oral) 50 mg twice daily (bid) 2. 5‐Loxin®‐BSO (oral) 50 mg bid 3. Placebo Ibuprofen will be used as a rescue medication for all groups. The study duration is 90 days and evaluations will be at baseline, 7, 30, 60 and 90 days. CONDITION: Osteoarthritis of knee ; Musculoskeletal Diseases ; Gonarthrosis [arthrosis of knee] PRIMARY OUTCOME: 1. Pain, assessed by VAS; 2. LFI; 3. Western Ontario and McMaster Universities osteoarthritis index (WOMAC)‐pain, WOMAC‐stiffness and WOMAC‐physical ability ; ; All primary outcomes will be measured at baseline, 7, 30, 60 and 90 days of the study. SECONDARY OUTCOME: 1. C‐Reactive Protein (CRP) ; 2. Matrix Metelloproteinase‐3 (MMP‐3) ; ; The secondary outcomes will be measured at baseline, 7, 30, 60 and 90 days of the study. INCLUSION CRITERIA: 1. Participants must understand risks and benefits of the protocol and able to give informed consent 2. Male and female subjects of 40‐80 years of age 3. Females of child bearing potential must agree to use an approved form of birth control and have a negative pregnancy test result 4. Unilateral or bilateral OA of the knee for more than 3 months 5. Visual Analogue Scale (VAS) score during the most painful knee movement between 40‐70 mm after 7 day withdrawal of usual medication 6. Lequesne's Functional Index (LFI) score greater than 7 points after 7 days of withdrawal of usual medication 7. Ability to walk 8. Availability for the duration of the entire study period