None listed
Conditions
Interventions
400mg per day ATTORI Celery Seed extract versus placebo for 8 weeks
Sponsors
ATTORI
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of painful OA of the hip or knee, with or without other joint involvement, as defined by:(i) hip or knee pain while standing, walking and/or in motion of at least 3 months duration, and(ii) evidence of one or more of the following features in an X-ray picture: osteophytes, osteosclerosis, cysts or joint space narrowing, and(iii) a WOMAC score not less than 20.Subjects who have given their informed written consent to participate.Subjects willing to discontinue their current OA treatment for the study duration, commencing at least 2 weeks prior to their first visit. This includes treatment with intra-articular injections, corticosteroids, NSAIDs, non-prescription therapies, chondroprotective agents, occlusive dressings, physiotherapy, or orthopaedic technical measures.Subjects of childbearing age who agree to continue using contraceptive measures for the duration of the study.
Exclusion criteria
Severe false alignment of the axis of the knee or hip.Surgery on the knee or hip within the past 2 months or arthroscopy within the past 2 months.Administration of intra-articular injections (e.g. corticosteroids, chondroprotective agents) or treatment with any long acting osteoarthritic therapy in the previous 2 months.Participation in another therapeutic trial within the previous 30 days.Infectious or inflammatory diseases.Female subjects who are pregnant or lactating.Subjects who are unwilling to comply with the study requirements including discontinuation of current osteoarthritis treatment.Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.Subjects with contra-indications to the study medication or to paracetamol.Reliance on the use of lipolytic, fibrinolytic, anti-coagulant or anti-inflammatory agents or agents that influence platelet function (especially aspirin, aspirin containing compounds and other NSAIDs).A history of trauma associated with the affected joints.Subjects with insulin dependent diabetes mellitus.Subjects with known hypersensitivity to celery.Subjects with any bleeding disorder.Subjects with a history of alcohol or substance abuseSubjects with significant gastrointestinal or renal disease.
Outcome results
None listed