An Observational, Randomized, open labelled, parallel group, two arm, study to evaluate safety and efficacy of Tab Nucart VG when compared with Glucosamine tablet in treatment of osteoarthritis.

Gufic Biosciences Ltd0 个研究点目标入组 66 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Patients willing to provide written informed consent and comply with study instructions for its duration.
•2. Healthy male or non-pregnant female aged 45 to 65 years with a clinical symptom of Osteoarthritis.
•3. Unilateral or bilateral osteoarthritis for more than 3 months
•4. Symptoms for at least 6 months prior to screening.
•5. Pain for 15 days of the preceding month (periarticular pain due to OA and not due to other conditions such as RA, bursitis, tendonitis, etc.).
•6. Had an X-ray of the target joints taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
•7. Females of child-bearing potential should have a negative serum pregnancy test prior to beginning therapy and agree to use adequate birth control during the study (acceptable methods include hormonal contraception maintained for a period of 3 months prior to the study and persisting through the study period, intrauterine device, barrier or abstinence).

•Recent injury in the area affected by osteoarthritis of the knee (past 4 months) and expectation of surgery in the next 4 months
•2. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g.,colitis) or fibromyalgia, underlying inflammatory arthropathy or severe rheumatoid arthritis
•3. Hypersensitivity to non-steroidal anti-inflammatory drugs, abnormal liver or kidney function tests, history of peptic ulceration and upper Gastrointestinal hemorrhage, congestive heart failure, hypertension, hyperkalemia.
•4. History of gastrointestinal bleeding or peptic ulcer disease.
•5. Intra-articular corticosteroid injections within the preceding 3 months
•6. Hyperuricemia ( >440 Î¼mol/l) and/or past history of gout
•7. Major abnormal findings on complete blood count, history of coagulopathies, hematological or neurological disorders8. Pregnant, breastfeeding, or planning to become pregnant during the studyObesity (body mass index > 30 kg/m2)
•10. X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
•11. Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the patient at risk by participating in the study.

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