A Randomized, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of HFPM-01 in Improving Pain, Stiffness, and Inflammation in Patients Suffering from Knee Osteoarthritis

Abstract

Objective: Osteoarthritis is a common chronic joint condition which causes stiffness and difficulty in moving, loss of muscle tone, strength and stamina. All these difficulties affect daily activities and quality of life and may also have an impact of mental health. Globally over 9.6% men and 18.0% women aged over 60 years has symptomatic osteoarthritis worldwide. It is the second most common rheumatologic problem and it is the most frequent joint disease with a prevalence of 22% to 39% in India. Considering the increasing prevalence and limitations of the conventional treatment for the management of Osteoarthritis, the current research aims at systematic clinical validation of the HFPM-01 in subjects primarily suffering from knee osteoarthritis. Materials and Methods: 90 subjects were enrolled in the study and were randomized to one of the three treatment groups. Subjects were undergoing clinical examination. Vitals were recorded. Blood samples were collected for readings of CRP. Subjective questionnaire scores evaluation was performed like SF-36 health survey score, VAS scale, WOMAC questionnaire. Changes in symptoms severity were noted like morning stiffness, tiredness, tenderness, and muscle spasms along with assessment of GI symptoms. Results: The change in WOMAC score, the increase in SF-36 score, the decrease in VAS score, the decrease in CRP levels, and the reduction in GI symptoms were found to be 33%, 308%, 60.44%, 52%, 40% respectively. Swelling, inflammation and pain was reduced from moderated to mild and eventually to no symptoms. Conclusion: This explains that HFPM-01 tablet is significantly effective in improving SF36 score WOMAC and VAS scale score. It is effective in reducing pain, swelling, and stiffness of knee joints, also improves the mobility of knee joints, and provides gastro protection being effective in managing pain and stiffness. HFPM-01tablet is safe and effective in the management of Osteoarthritis. Keywords: Osteoarthritis, WOMAC, VAS, CRP, Gastro protective.