Health Condition 1: M171- Unilateral primary osteoarthritisof knee
Conditions
Interventions
Intervention1: Curcuma longa extract: Dose: 300mg
Dosage form: Capsules
Route of administration: Orally
Frequency: 1 capsule orally once daily after food
Duration:90 Days
Control Intervention1: Pl
Sponsors
Daehan chemtech co., Ltd
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 having mild-to-moderate pain in knee joint upon completion of 30-second 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. 7.Subjects able to complete the 20-meter walk test.
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 received any corticosteroids, NSAIDs, glucosamine, chondroitin, and / or Curcuma longa extract within the past 90 days prior to the screening visit or any form of intra articular treatment / injections with corticosteroids 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 (greeter than2 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 have 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 or any natural health product, (excluding vitamins).
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 90Timepoint: Day 0,Day 30,Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in 20-meter walking time from baseline to Day 30, 60 and 90. 2. Change in SF-36 score from baseline to Day 30, 60 and 90. 3. Change in swelling index score from baseline to Day 30, 60 and 90. 4. Change in joint space narrowing (width) from baseline to Day 30, 60 and 90. Timepoint: Day 0,Day 30,Day 60 and Day 90;1. Change in TNF-alpha levels from baseline to Day 90. 2. Change in high-sensitivity C-Reactive Protein (hs-CRP) levels from baseline to Day 90. 3. Change in cyclooxygenase (COX) levels from baseline to Day 90. 4. Change in cartilage oligomeric matrix protein (COMP) levels from baseline to Day 90. 5. Change in C-telopeptide of type II collagen (CTX-II) levels from baseline to Day 90. 6. Change in C-propeptide of type II collagen (CP-II) levels from baseline to Day 90. Timepoint: Day 0 and Day 90;Safety Endpoints: 1. Adverse events (AEs) form Base line to End of the study 2. Abnormal findings in vital signs and medical interviews form Base line to End of the study 3. Abnormal changes in the hematology, Serum chemistry and Urine analysis results Base line and End of the study Timepoint: Day 0 and Day 90 | — |
Countries
India
Contacts
Public ContactDrShubarani M
Bangalore Clinical Services
Outcome results
None listed