Efficacy and Safety of a Highly Bioavailable Curcumin Formulation in Modulating Outcomes of Mild Knee Osteoarthritis: Multi-Centric, Randomized, Double-Blind, Placebo-Controlled Study
Bibliographic record
Abstract
Background: Osteoarthritis (OA) is a degenerative disease of joints affecting aging population worldwide with significant unmet medical needs.Here we report efficacy and safety of a highly bioavailable curcumin formulation, Curcuwin Ultra+ (CU+) in subjects with mild knee OA.Methods: Forty-five subjects each for CU+ 250 mg, CU+ 500 mg, and placebo groups with mild knee OA were randomized in a multi-centric, double-blind, parallel, placebo-controlled study with a treatment period of 84 days.A range of primary and secondary endpoints were assessed at baseline, day 5, 28, 56 and 84.The trial was prospectively registered on Clinical Trials Registry -India (CTRI/2021/10/037187) dated 08/10/2021.Results: A significant improvement (p<0.05) was observed in total Western Ontario McMaster Universities Osteoarthritis Index score (WOMAC), VAS pain, walking performance, range of motion (ROM) for knee extension and muscle strength as early as 5 days in CU+ 500 mg group as compared to placebo.Further, both groups of CU+ demonstrated significant reductions (p<0.05) in total WOMAC, WOMAC-pain, WOMAC-stiffness, WOMAC-physical function, VAS pain, and significant increases (p<0.05) in walking performance, knee extension and flexion muscle strength on days 28, 56, and 84 as compared to placebo.Moreover, ROM knee flexion was significantly decreased (p<0.05) on days 28, 56, and 84 in CU+ 500 mg and day 84 in CU+ 250 mg.Serum biomarkers like IL-1β, hsCRP, CTX-II and MMP3 were significantly reduced (p<0.05) on day 84 in CU+ 500 mg group.The use of rescue medication was significantly reduced
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".