A phase II, randomized, double-blind, placebo-controlled dose ranging pilot study investigating the efficacy and safety of supplementation with Arthrem in patients with hip and knee osteoarthritis
- Conditions
- Osteoarthritis of the hip or kneeAlternative and Complementary Medicine - Herbal remediesMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12614000259640
- Lead Sponsor
- Promisia Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 42
Pain from either or both knees and/or hips on most days of the previous 3 months combined with definite radiological changes of osteoarthritis
- Stable dose of current regular medication for at least 4 weeks prior to study entry
- A minimum score on a pre-screening visual analogue pain scale of at least 30 mm on a 100 mm scale averaged over the last 7 days
- Pregnancy/breastfeeding
- Significant renal or hepatic impairment
- Hip or knee surgery within past 6 months
- Current or recent (in the last 3 months) oral or intra-articular corticosteroid therapy;
- Co-morbid inflammatory arthritis such as rheumatoid arthritis
- History of hip or knee joint replacement or osteotomy at index joint
- Other previous hip or knee pathology such as a recent fracture (<3 months) or malignancy
- Significant illness other than osteoarthritis
- Taking any form of herbal/multivitamin/nutritional supplements for osteoarthritis (i.e. glucosamine, fish oil, green-lipped mussel) within 3 weeks
- Participation in another research study involving an investigational product in the past 12 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Western Ontario and McMaster Universities (WOMAC) index assesses pain, stiffness and functionality in patients with osteoarthritis.[0, 6, 12 weeks]
- Secondary Outcome Measures
Name Time Method