Health Condition 1: M171- Unilateral primary osteoarthritisof knee
Conditions
Interventions
Intervention1: Boswellia Extract: Dose:300mg Dosage form: Capsule frequency:One capsule orally in the morning before breakfast and one capsule before lunch in the afternoon : Duration 90 days
Control
Sponsors
Ingex Botanicals Private Limited
Bio Actives Japan KK
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory, male and female subjects 40-75 years of age. 2.KL (Kellgren-Lawrence) grade of 1 to 2. 3.At least 30 on 100 mm visual analogue scale. 4.Subjects who had 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 who were willing to refrain from taking Ibuprofen, Aspirin or other NSAIDs or any other pain reliever (OTC or prescription) during the entire trial. 6.Subjects who were 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 who had 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 who were expecting the surgery during the study duration period. 10. Female subjects, who are pregnant, breast feeding or planning to become pregnant. 11. Subjects who were having known allergy to non-steroidal antiinflammatory drugs NSAIDs including aspirin or has a suspected hypersensitivity, allergy or sensitivity to herbal products. 12. Subjects who had 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 had 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 hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurologic diseases, or malignancies, hypothyroidism. 17. Subjects with history of systemic lupus erythematous SLE. 18. Subjects with history of high alcohol intake 2 standard drinks per day. 19. Subjects with history of any psychiatric disorders that may impair the ability of subjects to provide written informed consent. 20. Subjects who had participated in any other trials involving investigational or marketed products within 90 days prior to the screening visit. 21. Subjects who are currently or within 30 days prior to the screening visit on prescription or OTC medications pain relievers such as Acetaminophen Paracetamol, Ibuprofen, Aspirin or other NSAIDs r any natural health product, excluding vitamins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: 1.Change in WOMAC total score 2.Change in WOMAC sub-score-pain, stiffness, physical function 3.Pain VAS 4.Change in Knee injury and Osteoarthritis Outcome Score (KOOS)Timepoint: Day 0 to day30, day60 and Day90. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: 1. Change in IL-6 2.Change in TNF-alpha levels 3.Change in C-Reactive Protein levelsTimepoint: day 0 and day 90 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed