NCT06134115

LIKEST Study: Lipocet® in Adults With Primary Knee Osteoarthritis Grade 3-4

Randomized Double-blinded Multi-center Study of Efficacy and Safety of Lipocet® in Patients With Primary Knee Osteoarthritis Grade 3 - 4

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pharmanutra S.p.a. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Primary Knee Osteoarthritis Grade 3 - 4

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lipocet® (food supplement)	1 sachet, 10 ml corresponding to 1500 mg of Cetylated fatty acids
DIETARY_SUPPLEMENT	Lipocet Placebo	Lipocet Placebo matching to Lipocet

Timeline

• Start date: 2022-08-19
• Primary completion: 2023-03-06
• Completion: 2023-05-18
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

3 sites across 1 country: Georgia