Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
None listed
Sponsors
Valyou Products Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 45 to 70 years 2. Participants have been diagnosed with OA of at least one knee by a general practitioner and/or orthopedic physician/surgeon. 3. Subject with knee pain for 3 months or more with a VAS rating score greater than 4 during the past week (0 equals no pain and 10 equals worst pain) 4. Subject without joint-related morning stiffness or with morning stiffness. 5. Patients ready to give written informed consent and willing to comply the study protocol 6. Patients who require anti-inflammatory treatment, do not use anti-inflammatory/analgesic medications on a regular basis, or are unsatisfied with their treatments and want to alter them. 7. Participants who have no plans to start new treatments during the study period
Exclusion criteria
Exclusion criteria: 1. Participants with a rapid aggravation of knee symptoms and a hot, swollen knee. 2. Participants with a history of knee replacement, significant trauma, joint injection, or arthroscopy in the preceding 6 months, or any major surgery in the previous year. 3. Participants either currently using anticoagulants or had taken pain relievers in the previous 3 months. 4. Participants with rheumatoid arthritis, septic arthritis, gout or pseudogout during the past 3 months, or a history of gout in the knee joint. 5.Participants with malignancy (bone pain), complicated pain disorders, or severe immobility. 6. Participants with uncontrolled medical conditions such as diabetes, uncontrolled hypertension, cardiovascular disease, gallbladder disease, renal disease, endocrine disease, or malignancies, neurological diseases, or psychiatric conditions. 7. History of peptic ulcer disease and/or GI bleeding/perforation 8. Use of systemic long-acting corticosteroids (for more than 10 days) or immune suppressants. 9. Participation in any other clinical trial within 30 days of screening. 10. Any history of allergy to any of the drugs/investigational products. 11. Planned for surgical intervention during the expected study duration. 12. Pregnant and lactating women and women of childbearing age who do not follow adequate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to end of Treatment in Visual Analogue Scale (VAS) ScoreTimepoint: Baseline, Week 12, Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to End of study in 6 Minute walk testTimepoint: Day 0, Week 12 & Week 24;Change from Baseline to End of Study in Bone Thickness (DEXA)Timepoint: Baseline, Week 12 and Week 24;Change from Baseline to End of Study in PGATimepoint: Week 12 and Week 24;Change from Baseline to End of Study in S MagnesiumTimepoint: Baseline, Week 12 and Week 24;Change from Baseline to End of Study in S PhosphorousTimepoint: Baseline, Week 12 and Week 24;Change from Baseline to End of Study in S. CalciumTimepoint: Baseline, Week 12 And Week 24;Change from Baseline to End of Study in SGATimepoint: Week 12 and Week 24;Change from Baseline to End of study in Stair Climb TestTimepoint: Baseline, Week 12 and Week 24;Change from Baseline to End of Study in Vitamin D3Timepoint: Baseline, Week 12 and Week 24;Change from Baseline to End of Study in X-RayTimepoint: Baseline, Week 12 and Week 24;Change from Baseline to end of Treatment in HsCRPTimepoint: Baseline, Week 12 And Week 24 | — |
Countries
India
Contacts
Public ContactDr Soumya Adiga
Valyou Products Private Limited
Outcome results
None listed