None listed
Conditions
Brief summary
The aim of the study is to investigate the impact of the herbal supplement Arthrem on arthritic pain, stiffness and functional limitation in participants with hip and knee osteoarthritis. Arthrem capsules have been on the market as a herbal supplement for arthritis since May 2011. Anecdotal evidence and feedback has been positive, however, no clinical safety or efficacy data exist. Broadening knowledge and obtaining evidence-based data from controlled clinical trials is increasingly accepted as necessary for the evaluation of the efficacy and safety of complementary and alternative medicines.
Interventions
Two active treatment groups will receive the dietary supplement Arthrem, an extract of the medicinal plant Artemisia annua. Subjects will receive one capsule (orally) twice daily in either 17 mg Arthrem group (total daily dose 34 mg) or the 34 mg Arthrem group (total daily dose 68 mg).
Compliance will be assessed by patient medication diaries and also by the return of unused capsules at each visit.
Duration: 12 weeks
There will be an optional, open-label, long term safety follow up study. Subj
Two active treatment groups will receive the dietary supplement Arthrem, an extract of the medicinal plant Artemisia annua. Subjects will receive one capsule (orally) twice daily in either 17 mg Arthrem group (total daily dose 34 mg) or the 34 mg Arthrem group (total daily dose 68 mg). Compliance will be assessed by patient medication diaries and also by the return of unused capsules at each visit. Duration: 12 weeks There will be an optional, open-label, long term safety follow up study. Subjects choosing to take part will receive 1x 17 mg capsule twice daily (total daily dose 34 mg) for up to 6 months after the double-blind 12 week study.
Sponsors
Promisia Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- 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
Exclusion criteria
- 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
Outcome results
None listed