Knee Osteoarthritis
Conditions
Brief summary
To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA.
Interventions
COMBINATION_PRODUCTGinkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)
120 mg leaf extract , twice daily in addition to Diclofenac 100 mg Once daily + paracetamol 1g Twice daily
COMBINATION_PRODUCTplacebo in addition to the standard treatment
placebo in addition to the standard treatment
Sponsors
Kufa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients 40-75 years old with knee OA. * Grade II and Grade III according to the Kellgrenn-Lawrence (KL) grading system of radiographic OA.
Exclusion criteria
* Pregnancy, breastfeeding * Liver or renal problems * Patient taking any drug that might interact with Ginkgo extract (eg. warfarin, etc.) * patient with cardiovascular or cerebral vascular disorders, uncontrolled diabetes, allergic to ginkgo, recent surgery or hospital admission, \>75 years old. * Allergic or contraindicated to using NSAIDs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KOOS score | Changes occured : baseline , 2 weeks , 4 weeks ,and 8 weeks | 42 item questionnaire to assess pain, other symptoms, activities of daily living (ADL), sport and recreation function (Sport/Rec) and knee-related quality of life (QOL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-6 | Changes occured: baseline , 4 weeks,and 8 weeks | Serum level of interleukin 6 |
| TNF-alpha | Changes occured: baseline , 4 weeks,and 8 weeks | Serum level of tumour necrosis factor - alpha |
| urinary CTX-II | Changes occured :baseline , 4 weeks,and 8 weeks | C-terminal telopeptide of type II collagen from urine samples |
Countries
Iraq
Outcome results
None listed