Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
None listed
Sponsors
Amrutanjan Health Care Limited, Tamil Nadu, India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR) criteria and confirmed with X-rays and with grade I and II as per Kellgren and Lawrence classification system and patients previously diagnosed with Rheumatoid arthritis (grade I and II) as per the American Rheumatism Association. 2. Have been on stable dose of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS) and other treatments for a minimum period of 3 months in the past. 3. Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS) 4. Patient should have not participated in any other clinical trial during the past 3 months. 5. Participants, who are willing to give written, signed and dated informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Recent history of trauma to the knee joint. 2. Having severe pain and inflammation, which is not getting controlled on NSAIDs 3. Uncontrolled diabetic patients with Hba1C greater than 10. 4. Pregnant or lactating 5. Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity 6. Suffering from any illness which will interfere with present study as decided by clinical investigator 7. History of hypersensitivity to any of the test products. 8. Any condition (like instability of knee joint, ligament tear or loose bodies in knee joint) decided as unfit for study by Clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Knee pain intensity measured by Pain VAS Scale ( 0- 100mm) 2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, Physical Function and Stiffness Subscale. 3. Changes in following laboratory parameters for all the patients: C Reactive Protein and ESR Change from base line to week 8 in the RA factor for RA patients. 4. Patients Global Assessment of Osteoarthritis or Rheumatoid arthritis patients. 5. Number of Participants with a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT OARSI). 6. Quality of life Questionnaires using Short Form Health 12. 7. X ray (knee joint) will be done at Baseline and at end of 8 weeks.Timepoint: Week 2, 4, 6 and 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability evaluation criteria: Adverse events and serious adverse events during the study period Laboratory (haematology and biochemistry) parameters (if any) Brief clinical examination Vital signs (pulse rate, respiratory rate, systolic and diastolic blood pressure, and body temperature)Timepoint: Week 2, 4, 6 and 8 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 Pvt Ltd
Outcome results
None listed