Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: Nucart VG: Its a herbal formulation in tablet form. Composition: Each Nucart-VG tablet contains
ï?· Boswellia serrata extract(600 mg) + Glucosamine sulphate 2KCL(750 mg)
ï?¶ Dosage & Du
Sponsors
Gufic Biosciences Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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 μmol/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to subsequent visits and EOT visit in the WOMAC pain score. ï?· An improvement in pain and physical functions by using standard tools (Visual analog scale for pain, Western Ontario & McMaster Universities Osteoarthritis Index) Quality of life questionnaire (EQ5D)Timepoint: Mean change from Day 0 to subsequent visits and Day 90 visit in the WOMAC pain score. ï?· An improvement in pain and physical functions by using standard tools (Visual analog scale for pain, Western Ontario & McMaster Universities Osteoarthritis Index) at day 0 and day 90. Quality of life questionnaire (EQ5D) at day 0 and day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| All adverse events (AEs) will be reported at each visit to allow a comparison between treatment groups.Timepoint: No of events occurring from screening to end of treatment | — |
Countries
India
Contacts
Public ContactMr Chandu Devanpally
Gufic Biosciences Ltd.
Outcome results
None listed