Abstract

Safety and Efficacy of Biosolve Curcumin in Active Rheumatoid Arthritis: A Randomized Double-Blind Placebo-Controlled Clinical Study

Rheumatoid Arthritis (RA) is a chronic inflammatory disease. Curcumin is wellknown to alleviate the symptoms of RA. Curcumin has low aqueous solubility and bioavailability, BioSOLVE Curcumin™ is a water-soluble and bioavailable form of curcumin. The safety and efficacy of BioSOLVE Curcumin™ in the complications of RA were assessed. A total of 24 participants were randomized to BioSOLVE Curcumin™ 250 mg and placebo group Supplementation was administered twice daily after food for 12 weeks consecutively. The demographic, efficacy (ACR-20 assessments, WOMAC index and VAS pain) and safety parameters were recorded at baseline and efficacy parameters were assessed on day 30, 60, 90 and safety parameters were assessed on day 90. All participants completed the study. The superior improvement was observed in ACR-20 criteria and WOMAC index in the BioSOLVE Curcumin™ 250 mg group as compared to the placebo group (p <0.05). A significant transition of participants from severe to moderate pain categories based on VAS was observed in the intervention group. No adverse events (AEs) or serious adverse events (SAEs) occurred throughout the study. The improvement in ACR-20, WOMAC index and VAS score indicates the improved efficacy of curcumin in the complication of RA when administered as BioSOLVE Curcumin™ at the selected dose.


Author(s): Shankaranarayanan Jeyakodi , Arunkanth Krishnakumaran Nai , Kalyan Janjanam Divya , Chandradhara P and Shubha Rani M    

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