Health Condition 1: M17- Osteoarthritis of knee
Conditions
Interventions
Intervention1: Xtagen SoloTM + SOC: Xtagen SoloTM administered for 45 days + SOC (Oral NSAIDs for the first 10 days and Physical Therapy for the 45 days)
Control Intervention1: SOC: Oral NSAIDs for t
Sponsors
Xania International DGMR LLC FZ
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women aged more than or equal to 30 to less than or equal to 75 years (both inclusive). 2. Diagnosis: Diagnosis of osteoarthritis of the knee joint established in accordance with the classification criteria of the American College of Rheumatology (ACR) and with X-ray signs of grade II or III according to the Kellgren-Lawrence classification. 3. Disease Activity: The WOMAC pain subscale score greater than or equal to 2 in the index knee or a VAS pain score between 40 mm and 90 mm in the index knee (with less than or equal to 30 mm in the contralateral knee). 4. Regular use of oral NSAIDs for knee pain on greater than or equal to 15 days per month in the 3 months prior to screening. 5. Consent: Able and willing to provide written informed consent. 6. Compliance: Willing to comply with study visits, treatment, and procedure. 7. Women patients willing to use effective methods of contraception throughout the study duration.
Exclusion criteria
Exclusion criteria: 1. Subjects will be excluded if CRP is more than 10 mg/L and/or ESR more than 30 mm/hr at screening, unless the principal investigator determines that these elevated values are due to a temporary, non-inflammatory condition and not related to an underlying rheumatologic disorder. 2. Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2. 3. Concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis etc.). 4. Significant (requiring surgical treatment) valgus or varus deformity of the knee joint, ligamentous laxity, or destruction of the meniscus. 5. Concomitant osteoarthritis of the hip and/or ankle joints, of severe grade, which may make it difficult to assess the pain in the target knee joint. 6. History of septic arthritis of any joint or suspected subacute infectious inflammation in the target knee joint. 7. History of surgery of the targeted knee joint. 8. Planned surgery on any joint of the lower extremities during the study. 9. Lymphovenous insufficiency of the lower limbs, grade III. 10. Diseases and concomitant conditions affecting the structure and density of bone tissue (osteodystrophy due to hyperparathyroidism, malabsorption syndrome, osteomalacia, osteogenesis imperfecta, etc.). 11. History or current severe cardiovascular diseases, including: NYHA Class III or IV chronic heart failure, clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary vessel surgery, significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure more than 180 mm Hg and diastolic blood pressure more than 110 mm Hg, pulmonary embolism or deep vein thrombosis. 12. History of Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus (HbA1c more than 8.5 percent and/or fasting plasma glucose more than 180 mg/dl at screening or episodes of severe hypoglycaemia 1 month); HbA1c report within 60 days is acceptable. 13. Subjects with BMI more than or equal to 40 kg/m2. 14. Severe diseases of the central nervous system, including seizures in history or conditions that may lead to their development; stroke or transient ischemic attack within 12 months prior to screening; head injuries or loss of consciousness within 12 months prior to screening; a brain tumor. 15. Diseases manifested by increased bleeding (hemorrhagic diathesis, haemophilia, thrombocytopenia, etc.), or conditions with a high risk of bleeding. 16. Significant uncontrolled concomitant disease, such as neurological, renal, hepatic, endocrine and gastrointestinal which according to the Investigator, could prevent the patient from participating in the study. 17. Participation in other clinical studies or administration of investigational products within 4 weeks prior to screening. 18. HIV, active viral (hepatitis B and C) or a cirrhotic liver disease in medical history. 19. Malignancies within the last 5 years (except for basal cell carcinoma of the skin and cervical cancer in situ that had undergone surgical removal or treatment). 20. History or current use of Drug of abuse, excessive alcohol intake, which in the opinion of the Investigator, makes the patient unsuitable fo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in WOMAC scores between treatment groups (Xtagen SoloTM for 45 days + 10 days SOC vs 10 days SOC alone) from baseline to Week 6 (Day 45 2) in patients with osteoarthritis of knee joints in Indian population. Timepoint: Day 1 Week 0, Day 21 Week 3 and Day 45 Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in WOMAC scores with Xtagen SoloTM therapy administered for 45 days in conjunction with a 10 days regimen from baseline to Week 3 Day 21 2. Proportion of patients classified as responders according to the OMERACT OARSI responder criteria at Week 3 Day 21 & Week 6 Day 45 3. Change in the Patient Global Pain Assessment (VAS) score from baseline to Week 3 Day 21 & Week 6 Day 45 4. The Change in EQ 5D scores from baseline to Week 3 & Week 6 Day 45 Timepoint: Day 1 Week 0, Day 21 Week 3 & Day 45 Week 6 | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
CliniExperts Research Services Pvt Ltd
Outcome results
None listed