Knee joint discomfort
Conditions
Interventions
Group 1: Chondractiv Plus™ 2000 mg, oral, 2 x 3 capsules/day (morning and evening), Intervention: 12 weeks
Group 2: Chondractiv Plus™ 1500 mg, oral, 2 x 3 capsules/day (morning and evening), Intervent
Sponsors
DIANA SAS
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 3. BMI <32 kg/m2 4. Activity-related knee pain or discomfort during daily life on 3-7 days a week since at least 3 months 5. Maximum pain during daily life activity of 30-80 (VAS Scale 0-100 mm) 6. No permanent knee pain at rest 7. Subject is in good physical and mental health as established by medical history, physical examination, vital signs, ECG, results of biochemistry, hematology
Exclusion criteria
Exclusion criteria: 1. Relevant history or presence of any severe medical disorder, potentially interfering with this study, e.g. primary knee joint disease (osteoarthritis, rheumatic or bacterial/viral inflammation), malabsorption, chronic gastro-intestinal diseases (colitis ulcerosa, Crohn’s IBS, acute peptic ulcers, celiac disease), heavy depression, diabetes, heavy liver disease, immunodeficiency, pancreatic insufficiency, renal insufficiency, acute cancers within last 3 years except basal cell carcinoma of the skin 2. Recent trauma ( 5% during last 3 months 12. Anticipating any planned changes in lifestyle for the duration of the study 13. Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint discomfort assessed with Knee injury and Osteoarthritis outcome Score (KOOS) (global score) (Baseline, after 6 weeks and after 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Subscales of KOOS (pain, symptom, activity of daily living, sport and recreation function, quality of life) (baseline, after 6 weeks and after 12 weeks) • Responder rate in orientation to OMERACT-OARSI based on KOOS questionnaire (after 12 weeks) • Knee joint discomfort during daily life activities: Frequency and intensity (baseline and biweekly assessments over 12 weeks) • Pain score (VAS) (maximal pain while performing the single leg step-down test at visit 3) (after 12 weeks) • Knee mobility (range of motion (ROM) (passive and active)) (baseline and after 12 weeks) • Function tests: chair stand up test, 40 m fast paced walk test, stair climb tests (baseline and after 12 weeks) • Quality of Life (SF-36) (baseline and after 12 weeks) • Blood cartilage biomarker COMP and PIINP (baseline and after 12 weeks) • Global assessment of efficacy in target knee (after 12 weeks) • Global assessment of efficacy on other joints (after 12 weeks) | — |
Countries
Germany
Outcome results
None listed