Moderate osteoarthritis of the knee Musculoskeletal Diseases Osteoarthritis
Conditions
Interventions
Reparagen, a combination of a cat's claw extract (Uncaria guianensis), a herbal medicine from the Amazon, and RNI 249, an extract of maca (Lepidium meyenii) a vegetable native to the Andes compared to
Sponsors
Santerra Pharmaceuticals LLC (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ambulatory adult patients of either sex >20 years of age 2. Patients with moderate osteoarthritis of the knee, clinically detected and/or diagnosed as per radiological examination and American Rhematology Association (ARA) functional classification 3. ARA functional class II or III 4. Kellgren Lawrence for knee osteoarthritis grade II, grade III 5. Patient's assessment of overall pain score between 40 and 100 mm on a pain-visual analogue scale after washout period
Exclusion criteria
Exclusion criteria: 1. Arthritis other than osteoarthritis 2. Arthroscopy of either knee in the past year 3. Administration of intraarticular steroids within the past three months or hyaluronic acid in the last nine months 4. Known adverse responses to non-steroidal anti-inflammatory drugs (NSAIDs), suspected hypersensitivity, allergy or other contraindication to any compounds present in the study medication 5. Significant gastrointestinal (GI) diseases or previous GI upset to NSAID administration 6. Pregnant or lactating women or woman of child-bearing age not following adequate contraception 7. Evidence of severe renal, hematopoetic disease or severe cardiac insufficiency as revealed by laboratory investigations and other tests 8. Moderate to severe peripheral neuropathy or other neurological disorders 9. Unwilling or unable to come to regular follow-up studies 10. Any condition which in the opinion of the investigator does not justify patient inclusion in the study 11. Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain visual analogue score 2. Modified Western Ontario and McMaster University osteoarthritis index (WOMAC) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum insulin-like growth factor-1 (IGF-1) 2. Global assessment of therapy 3. Patient's opinion 4. Consumption of rescue medication | — |
Countries
India
Outcome results
None listed