Health Condition 1: M179- Osteoarthritis of knee, unspecified Health Condition 2: null- Osteoarthritis of the knee.
Conditions
Interventions
Intervention1: DPOR/JR2007: 1 Tablet â??Twice daily after meals for 12 weeks.
Control Intervention1: NIL: NIL
Sponsors
Deltas Pharma
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient between >= 40-75 years of age, (inclusive of both), previously diagnosed (3 months prior to screening) with osteoarthritis of knee (as per ACR criteria for osteoarthritis of knee) based on clinical findings. 2. Primary knee OA according to ACR criteria - patients having knee pain and any 3 of the following determined by physical examination: less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement, and no palpable warmth of synovium. 3. Patient with moderate-severe pain (Score 1.5 - 2.5 on Likert scale of 5 in pain sub-score question 1 of WOMAC INDEX (Modified CRD version) 4. Patient able to understand and follow study procedures, also willingness to adhere to treatment. 5. Patient who agrees to participate in the study by giving his/her written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient having Body Mass index >=32. 2. Patient suffering with psoriatic arthritis or having history of any other autoimmune diseases. 3. Patient with clinically significant trauma or surgery in the target knee. 4. Administration of NSAIDs within the 7 days prior to the inclusion in the study. 5. Administration of any intra-articular treatment, glucosamine sulphate, chondroitin sulphate within the 3 months prior to their inclusion in the study. 6. Patients suffering from severe systemic disease. 7. History of hypersensitivity to any ingredient of the Investigational product. 8. Subject received long term systemic Ayurvedic, Homeopathic or Herbal drug, three months prior to screening visit. 9. Pregnant or lactating women. Women of child-bearing age not using effective contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in pain as per question 1 of WOMAC INDEX (Modified CRD version) at the end of treatment.Timepoint: Week 0 to Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in WOMAC Domain A; questions 1 and 2 (pain with movement) between baseline and weeks 4, 8, and 12 2. Change in WOMAC Domain B (stiffness) between baseline and weeks, 4, 8, and 12 3. Change in WOMAC Domain C (physical function) between baseline and weeks 4, 8, and 12 4. Change in PGA between baseline and weeks 4, 8, and 12 5. QOL (SF-8 score) at baseline, weeks 4, 8, and 12 6. Use of rescue analgesia (amount of acetaminophen and ibuprofen used) Timepoint: 1. Change in WOMAC Domain A; questions 1 and 2 (pain with movement) between baseline and weeks 4, 8, and 12 2. Change in WOMAC Domain B (stiffness) between baseline and weeks, 4, 8, and 12 3. Change in WOMAC Domain C (physical function) between baseline and weeks 4, 8, and 12 4. Change in PGA between baseline and weeks 4, 8, and 12 5. QOL (SF-8 score) at baseline, weeks 4, 8, and 12 6. Use of rescue analgesia (amount of acetaminophen and ibuprofen used) | — |
Countries
India
Contacts
Public ContactDr Aasin Maurya
Integrity Healthcare Services
Outcome results
None listed