SMPL

New Delhi [India], January 28: CliniExperts, one of India's premier Clinical Research Organizations, successfully conducted a phase III study on its biotherapeutic product, ALFLUTOP®, to assess the efficacy, safety, and tolerability in Indian patients with knee osteoarthritis. Such a scientific study proved ALFLUTOP® not just efficacious but could help in drastically improving the quality of life of patients in India, where osteoarthritis increasingly becomes a huge public health problem.

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The study sought to fill a significant void in the current literature concerning the efficacy of ALFLUTOP® within the Indian demographic. Although the product has been available in the market for 27 years, showcasing a reliable and stable safety profile, the particular effects and safety of ALFLUTOP® in Indian patients had not been comprehensively investigated prior to this study. CliniExperts established a robust study design that involved 218 evaluable subjects, aged 40 to 75 years, who were randomly assigned to receive either ALFLUTOP® or standard care treatment over a duration of 56 days.

The clinical trial was structured as a prospective, randomized, double-blind, multicentric phase III study carried out at seven locations throughout India. Participants were administered either ALFLUTOP®, a natural chondroprotective product known for its anti-inflammatory properties, or standard care treatment over a duration of 20 days. The study comprised four distinct visits, facilitating comprehensive monitoring and assessment of the outcomes.

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The primary endpoints were the percent change in WOMAC scores, a standardized process for assessing the impact of osteoarthritis on a patient's quality of life. Findings were striking out of 218 evaluable subjects, patients in the ALFLUTOP® group demonstrated a reduction in WOMAC pain score at week 4 by 29.4% in comparison with only 11.9% in the standard care group. By Week 8, the relative reduction of pain scores for ALFLUTOP® appeared to have increased to 45.7%, significantly outpacing that seen in the standard care group by 33.2%. The difference was statistically significant with a p-value

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