The purpose of this study is to assess the safety, tolerability and efficacy of Lipocet® (food supplement) in patients with primary knee osteoarthritis grade 3 - 4
After being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. Patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Lipocet ® (once a day, 10 ml corresponding to 1500 mg of Cetylated fatty acids) or placebo (once a day, 10 ml) during 60 days of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
1 sachet, 10 ml corresponding to 1500 mg of Cetylated fatty acids
Lipocet Placebo matching to Lipocet
LLC "Altra Vita"
Tbilisi, Georgia
JSC "Evex Hospitals" (Caraps Medline)
Tbilisi, Georgia
LLC "Unica"
Tbilisi, Georgia
Change From Baseline in Pain on the Visual Analogue Scale (VAS scale) on day 60
Visual analogue scale (VAS) is a validated questionnaire assessing pain intensity during 60 days of treatment. Possible scores range from 0 cm (no pain) to 10 cm (Pain as bad as it could be). Change = (Day 60 - Baseline Score).
Time frame: From Baseline to Day 60
Change From Baseline in Knee Range Of Motion (ROM) on day 60
Flexion, Extension, External rotation, Internal rotation were measured in degrees. Change = (Day 60 - Baseline Result).
Time frame: From Baseline to Day 60
Change From Baseline in WOMAC Total score (Western Ontario and MCMaster Osteoarthritis Index Questionnaire) on day 60
WOMAC is a validated questionnaire assessing functionality during 60 days of treatment. Possible scores result from 0 to 96 score. Change = (Day 60 - Baseline Score). The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.
Time frame: From Baseline to Day 60
The number and % of patients with treatment-emergent adverse events
Incidence and severity of adverse events (AEs) that occurred during the treatment
Time frame: From Baseline to Day 60
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