An open label, prospective, clinical study on a polyherbal formulation in osteoarthritis of knee.

ABSTRACT

Background: Currently, though pharmacological, mechanical, and surgical interventions are used, there is no known cure for osteoarthritis (OA). Objectives: The main aim of the study was to assess the effi cacy and safety of “TLPL/AY/03/2008,” a polyherbal formulation on knee joint pain assessed on visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Materials and Methods: It was an open label, single center, prospective, clinical study conducted in 36 patients of OA Knee. Two capsules of ‘TLPL/AY/03/2008’ were given to all patients twice daily orally after meals for 180 days. Results: Data describing quantitative measures are expressed as meanSD. Comparison of variables representing categorical data was performed using Chi-square test. The mean joint pain (as assessed on VAS) reduced signifi cantly (59.85%; P0.05) and the mean WOMAC combined score, WOMAC pain sub-score, WOMAC stiffness sub-score, and WOMAC diffi culty sub-score also reduced signifi cantly at the end of the study. The mean time taken by the patients to walk 50 feet too, was reduced signifi cantly (25.26%) at the end of the study. At the end of 4 months of the treatment, no patient needed paracetamol as rescue medicine to control pain. Most of the patients had shown good overall improvement assessed by the physician and by the patients. Majority of the patients showed excellent tolerability to the study drug. No signifi cant change in most of the safety laboratory parameters was observed at the end of the study. Conclusion: The study provides good evidence in support of the effi cacy and safety of the ‘TLPL/AY/03/2008’ in OA of knee.