Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: CurQfen: 400mg capsule one per day for 84 days
Control Intervention1: Chondroitin sulfate plus Glucosamine hydrochloride: Chondroitin Sulfate 400 mg plus Glucosamine hydrochloride 415
Sponsors
Akay Flavours and Aromatics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subject with OA (Class I â?? III), according to Kellgren and Lawrence system and confirmed by X ray, who have been completely withdrawn from their previous analgesics or anti-inflammatory medications or have been newly diagnosed with mild to moderate primary knee OA, and who are not currently taking any analgesics or anti-inflammatory medications 2 Subjects willing to perform walking test and ready to fill up the questionnaires 3 Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 4 Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study
Exclusion criteria
Exclusion criteria: 1 Subjects with OA secondary to a known disorder: Rheumatoid arthritis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, any history of fracture involving the study joint, or any other type of arthritis. 2 Subjects who had surgery, or arthroscopy within three months prior to inclusion 3 Subjects who have been administered hyaluronic acid injections within six months prior to inclusion 4 Subjects with severe bone or joint deformation or condition 5 Subjects who have used glucosamine and/or chondroitin containing compounds within seven days prior to the screening visit 6 Subjects with a body mass index (BMI) >= 28 kg/m2 7 Subjects who have used medications with matrix metalloproteinases-inhibitory properties (e.g. tetracycline or structurally related compounds) or took corticosteroids (systemic, >10 days duration) within 28 days of Screening Visit. 8 Subjects with a known allergy to herbal products and nonsteroidal anti-inflammatory drugs 9 Subjects with autoimmune complications 10 Subjects with any oncological condition 11 History of cardiovascular, type 2 diabetes mellitus, pulmonary, hepatic and renal problems 12 Subjects with abnormal biochemical or haematological values at screening 13 Any condition that in opinion of the Investigator, does not justify the subjects participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change in WOMAC questionnaire from baseline to end of the treatment 2. â?¢ Mean change in Karnofsky performance scale score from baseline to end of treatment 3. â?¢ Mean change in Visual Analogue Scale score from baseline to end of treatmentTimepoint: Day 0, Day 28, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Biochemical markersTimepoint: Day 0, Day 84;Change in Hematological and Biochemical ParametersTimepoint: Day 0, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Private Limited
Outcome results
None listed