Health Condition 1: M199- Osteoarthritis, unspecified site
Conditions
Interventions
None listed
Sponsors
MAKAMS Industries Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR) criteria (Class III) and confirmed with X-rays and grade 3 or 4 as per Kellgren and Lawrence classification system and patients suffering from low back ache over the past 3 months. 2. Have been on stable dose of prescription Nonsteroidal Anti- Inflammatory Drugs (NSAIDS), or acetaminophen of at least 2000 mg per day for at least 20 days in the past month. 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. Patients, who are willing to give written, signed and dated informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Arthritis of the knee from other causes and Lumbar spondylosis. 2. Uncontrolled hypertension (180/100) or Diabetes (HbA1c greater than 10) 3. Have OA pain that requires treatment with potent opioids, systemic corticosteroids, intra-articular injections, duloxetine, or venlafaxine 4. Moderate to severe renal impairment 5. Pregnant or lactating 6. Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity 7. Suffering from any illness which will interfere with present study as decided by clinical investigator 8. History of hypersensitivity to any of the test products. 9. Any condition decided as unfit for study by Clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline to 8 weeks in knee and back pain intensity measured by pain VAS Scale (0 to100 mm) 2. Change from baseline to 8 weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. 3. Changes from base line to 8 weeks in following laboratory parameter(s): Hs C Reactive Protein ESR 4. Change in baseline to 8 weeks in Patients Global Assessment of osteoarthritis and low back ache. 5. Number of patients 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. Changes from baseline to 8 weeks in Quality of life- Questionnaires (Short Form Health 12).Timepoint: Day 0, week 4 and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate safety and tolerability of study product by clinical AEs, including laboratory abnormalities (If any) Safety and tolerability evaluation criteria: Adverse events and serious adverse events during the study period Laboratory parameters- CBC, RFT, LFT, HbA1c and RBS (pre and post study) Timepoint: Day 0 and week 8 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 Private Limited
Outcome results
None listed