A Clinical study to evaluate the Safety and Efficacy of CurQfen in mild to moderate Knee Osteoarthritis Patients.

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1Subject 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 III), according to Kellgren and Lawrence system and confirmed by X ray, who have been completely withdrawn from their previous analgesics or anti-inflammatory medications or have been newly diagnosed with mild to moderate primary knee OA, and who are not currently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

2Subjects willing to perform walking test and ready to fill up the questionnaires

3Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening

4Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study

Exclusion Criteria

1Subjects 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.

2Subjects who had surgery, or arthroscopy within three months prior to inclusion

3Subjects who have been administered hyaluronic acid injections within six months prior to inclusion

4Subjects with severe bone or joint deformation or condition

5Subjects who have used glucosamine and/or chondroitin containing compounds within seven days prior to the screening visit

6Subjects with a body mass index (BMI) >= 28 kg/m2

7Subjects 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.

8Subjects with a known allergy to herbal products and nonsteroidal anti-inflammatory drugs

9Subjects with autoimmune complications

10Subjects with any oncological condition

11History of cardiovascular, type 2 diabetes mellitus, pulmonary, hepatic and renal problems

12Subjects with abnormal biochemical or haematological values at screening

13Any condition that in opinion of the Investigator, does not justify the subjects participation in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean change in WOMAC questionnaire from baseline to end of the treatment <br/ ><br>2. â?¢Mean change in Karnofsky performance scale score from baseline to end of treatment <br/ ><br>3. â?¢Mean change in Visual Analogue Scale score from baseline to end of treatmentTimepoint: Day 0, Day 28, Day 42, Day 84

Secondary Outcome Measures