Conditions: Knee Osteoarthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 158
Healthy volunteers: no

Brief summary:
The main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.

Detailed description:
The purpose of this study is to determine whether a new combination of chondroitin sulfate and glucosamine sulfate administered once a day is superior to placebo in the treatment of patients with moderate to severe knee osteoarthritis. Eligible patients will be randomized 1:1 and the treatments will be administered for 24 weeks. Clinical efficacy at the end of treatment will be evaluated. Safety will be evaluated through adverse events recoding during the study period.

Arms:
arm 1: Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks arm 2: Placebo of chondroitin sulfate + glucosamine sulfate orally administered once a day for 24 weeks

Interventions: intervention 1: CS+SG intervention 2: Placebo
Intervention descriptions: intervention 1: Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks. intervention 2: Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.

Protocol document: