M19.09
Conditions
Interventions
Group 1: 1 g CAVACURMIN®: cyclodextrin inclusion complex of curcumin with gamma-Cyclodextrin (equivalent to 160 mg Curcuminoides) for 8 weeks.
Group 2: 1 g Cellulose
Sponsors
Wacker Chemie AG
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: Women and men with painful knee joints e.g. defined as e.g. WOMAC pain score part A + stiffness score part B at least 15 points; Volunteers with primary osteoarthritis who are not expected to require surgical treatment for at least three months after inclusion; Known X-ray finding (Kellgren score of 1 to 3; X-ray not older than 24 months); Discomfort over a period of at least 3 months
Exclusion criteria
Exclusion criteria: BMI = 32 kg/m2, Medical treatment of joint disease besides Paracetamol as analgesic medication for emergency treatment; Inflammatory, infectious or metabolic joint disorder; Artificial joint replacement in knees or hip; Surgery within the last 6 months in knees or hip; Intra-articular therapy within the last 3 months; Oral cartilage treatment within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum score of Pain and Stiffness (Part A + Part B WOMAC score) after 4 and 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| After 8 weeks: Part A, B, C WOMAC; KOOS quality of life; KOOS sport and recreation; Performance-based tests (30s chair stand test, 40m fast-paced walk test, stair climb test); Global assessment; Reduction of analgetic medication; SF-36; Inflammatory markers (e.g. hs-CRP, cytokine panel) | — |
Countries
Germany
Contacts
Public ContactKatharina Knaub
BioTeSys GmbH
Outcome results
None listed