Health Condition 1: M171- Unilateral primary osteoarthritisof knee
Conditions
Interventions
Intervention1: Boswellia serrata extract: Dose: 250g
Dosage form: Capsules
Frequency: 2 capsules to be consumed orally at a time once daily after food
Total dose: 500mg
Control Intervention1: Place
Sponsors
Daehan chemtech co.,Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory, male and female subjects 40 to 75 years of age. 2. KL (Kellgren Lawrence) grade of 0 to 2. 3. At least 30 on 100mm visual analogue scale. 4. Subjects having mild-to-moderate pain in knee joint upon completion of 30 sec Chair Stand Test or 80 meter Fast-Paced Walk Test, and otherwise no knee pain at rest. 5. Subjects willing to refrain from taking Ibuprofen, Aspirin or other NSAIDS or any other pain reliever (OTC or prescription) during the entire trial. 6. Subjects willing to sign the informed consent and comply with study procedure
Exclusion criteria
Exclusion criteria: 1. Subjects with any possible signs / indication / history of arthritis, joint disorders including dislocations and quadriceps tendons tear. 2. Subjects with history of underlying inflammatory arthropathy or severe RA or OA. 3. Subjects having used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders. 4. Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation. 5. Subjects with BMI less than 18.5 or more than 30. 6. Subjects who consumed the medicines or supplements related with joint health within 30 days before screening visit. 7. Subjects who are not acceptable for the test by the judgment of PI. 8. Subjects with the history of tobacco smoking. 9. Subjects expecting the surgery during the study duration period. 10. Female subjects, who are pregnant, breast feeding or planning to become pregnant. 11. Subjects having known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to herbal products. 12. Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol. 13. Subjects with history of gout. 14. Subjects who have taken corticosteroid, indomethacin, glucosamine+ chondroitin, within 90 days prior to the screening visit or intra-articular treatment / injections with corticosteroid or hyaluronic acid within 90 days preceding the screening visit. 15. Subjects with the history of congestive heart failure or any vascular conditions. 16. Subjects with the evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurologic diseases, or malignancies, hypothyroidism. 17. History of Systemic Lupus Erythematous (SLE). 18. High alcohol intake ( >2 standard drinks per day). 19. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 20. Participation in any other trials involving investigational or marketed products within 90 days prior to the screening visit. 21. Subjects who have consumed Acetaminophen / Paracetamol, Ibuprofen, Aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 30 days prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in WOMAC total score from baseline to Day 30, 60 and 90. 2. Change in WOMAC sub-score: pain, stiffness, physical function from baseline to Day 30, 60 and 90. 3. Pain VAS from baseline to Day 30, 60 and 90. 4. Lequesne Functional Index from baseline to Day 30, 60 and 90 Timepoint: Day 0,Day 30,Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in SF-36 questionnaire from baseline to Day 90. 2. Change in TNF-alpha from baseline to Day 90. 3. Change in C-Reactive Protein from baseline to Day 90. Timepoint: Day 0 and Day 90 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt. Ltd
Outcome results
None listed