Osteoarthritis is the second most common rheumatologic problem and it is the most frequent joint disease with a prevalence of 22% to 39% in India. The present study is planned to validate clinical safety and efficacy of HFPM-01, in osteoarthritis. It is high-quality products with the amalgamation of highest quality standards followed with the traditional knowledge of the selection of ingredients. By virtue of the ingredients used and the product development with quality standards, it can prove efficacious in the management of symptoms of osteoarthritis as well as improving quality of life and offering gastroprotection.

A randomized, parallel arm, controlled clinical trial was conducted to evaluate the efficacy and safety of HFPM-01 in improving pain, stiffness and inflammation in patients suffering from knee osteoarthritis. Ninety patients of either sex in the age group of 40 to 70 years with clinical and radiological evidence of osteoarthritis were selected for the trial. The patients were randomly divided into three groups. Group A patients received HFPM-01 at a dose of 1 tablet thrice daily, and Group B received Glucosamine sulphate 500 mg trice a day and group 3 received NSAIDS as per requirement to manage symptoms. If needed the analgesics were offered to subjects from test and glucosamine group as a rescue.

All symptoms along with severity and duration were recorded prior to the drug treatment. Routine blood chemistry along with inflammatory marker CRP were done before and at the end of the treatment period to assess any changes. Patients were followed up every 4 weeks for 3 months.

Symptomatic assessment was carried out at day 7, day 15, Day 30, 60 and 90. It was evident from the fact that onset of relief from the pain and stiffness was started from 7^th day as per subject reported scale.

The pain, inflammation and stiffness was assessed through WOMAC questionnaire, it was found from the data that there was 33, 39.7 and 3.5% decrease in WOMAC score from baseline to day 90 in HFPM-01, Glucosamine and Placebo group respectively. There was significant decrease in WOMAC score after treatment with HFPM-01 and Glucosamine.

The % reduction in Visual Assessment Score for pain was 53.16, 55.22 % decrease in VAS score from baseline to day 90 in HFPM-01 and Glucosamine group respectively. In case of placebo group there was 20% increase in VAS pain score. There was significant decrease in VAS score after treatment with HFPM-01 and Glucosamine.

There was significantly improved quality of life of subjects after treatment with HFPM-01 and Glucosamine.

The symptoms of arthritis like Morning stiffness, tiredness, tenderness, muscle spasm, swelling were reduced significantly after treatment of HFPM-01 and Glucosamine.

The joint flexibility and weight bearing capacity was improved after treatment of HFPM-01 and Glucosamine.

Serum CRP levels were measured in all the groups. Serum CRP levels were raised in subjects at baseline. In HFPM-01 treated group, serum CRP levels were reduced by 30% at end of study when compared to placebo. When compared to % reduction of serum CRP between HFPM-01 and glucosamine treated group

Subjects experiencing GI symptoms like heartburn and constipation were relieved of these symptoms in HFPM-01 treated group by the virtue of gastro protective action and effect of reduced intake of NSAIDS required for management of pain for 3 months. The gastro protective activity was better in HFPM-01 treated group than Glucosamine and placebo treated groups.

Total of 15% of population of HFPM-01 treated group, 25% of Glucosamine and 40% in control group used NSAID as a rescue medication during 90 days period. There was reduction in requirement of NSAID in managing pain.

There was significant reduction in CRP levels in HFPM-01 treated group compared to control group. This could explain the anti-inflammatory potential of HFPM-01.

90% of HFPM-01 treated group and 50% in glucosamine treated group were satisfied with the drug and showed significant improvement in the symptoms and mobility. In control group only few patients expressed their satisfaction to relief in pain. No adverse events related to the HFPM-01 use were reported by any of the patients.

HFPM-01 presented better management of pain related stress reported by subjects.

HFPM-01 improved joint comfort and mobility. It significantly improved muscular energy and vitality thus overall quality of life.

The investigational product HFPM-01 found to be safe and effective in management of osteoarthritis.