A Randomized Double-blinded Placebo-controlled Study to Determine the Efficacy of Rhuleave-K on Subjects with Mild to Moderate Osteoarthritis
Notice bibliographique
Résumé
Background Osteoarthritis (OA) is a common degenerative joint disorder characterized by pain, stiffness, and reduced mobility, impacting the quality of life. Extracts from turmeric (Curcuma longa) and Boswellia (Boswellia serrata) have shown significant anti-inflammatory effects. Rhuleave-K has been formulated as a natural combination of turmeric extract, Boswellia extract in sesame oil using Speed Technology. Objectives The present clinical investigation assessed the efficacy and safety profile of Rhuleave-K in comparison to a placebo, among subjects with mild-to-moderate osteoarthritis (OA). Materials and Methods This randomized, double-blind, placebo-controlled study enrolled 100 subjects with mild to moderate OA symptoms (Kellgren–Lawrence (KL) grade 2–3) and pain intensity >5 on the Numerical Rating Scale (NRS). Participants were administered either 500 mg of Rhuleave-K soft gel capsules (turmeric extract, Boswellia extract, and sesame oil as key components) as a test product or a matching placebo once daily for 12 weeks. The primary outcome was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at the end of the study. The secondary outcomes included Osteoarthritis Research Society International (OARSI) battery tests and NRS scores. Data were recorded at baseline and on day 5, week 6, and week 12. Safety assessments, including blood biochemistry and vital signs, were performed at baseline and week 6 and week 12. Results The test group showed a significant improvement in the total WOMAC score of 55% ( p < .001), whereas there was a negligible change (0.72%) in the placebo group. The WOMAC pain reduction was 75% ( p < .001), WOMAC stiffness was 67% ( p < .001), and WOMAC functional limitation was 48% ( p < .001) from baseline. There were significant improvements in the OARSI battery of tests, such as the 40 m fast-paced walk by 10%, nine-step stair negotiation (9SSN) by 1%, 30 s chair stand test by 34%, timed up and go test by 18%, and 6 min walk test by 8% from baseline. The range of motion, as measured by goniometry, showed significant improvement (mean difference 2.06° ± 1.24°, p < .001) in flexion, whereas there was no change in the placebo group. C-reactive protein (CRP) showed a clinically significant 77% decrease, and complete blood count (CBC), liver function test (LFT), and renal function test (RFT) showed statistical significance, but no clinically significant changes, and no adverse events were evident in either the test or the placebo group during the study period. The treatments were well tolerated in the present study. Conclusion Rhuleave-K, at a daily dose of 500 mg for 12 weeks, significantly decreased pain, joint stiffness, difficulty in physical function, and mobility associated with mild-to-moderate OA compared with placebo. The improvement was observed as early as 6 weeks and can be a safe and suitable addition to the current management of OA.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,005 | 0,001 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,009 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».