At the screening visit, investigators confirmed the
inclusion criteria and performed physical assessment of
the involved knee. Subjects who fulfilled the enrollment
criteria were given study information and a signed
informed consent was obtained from them. Then a
compilation of the demographic data, medical and
medication history was obtained & vital signs were
assessed. Subjects were asked to return for the baseline
visit, after a washout period of 7 days if required.
At the baseline visit complete medical and physical
examination was performed, BMI and fasting blood
sample were measured, concomitant medications were
noted and the WOMAC symptom assessment
questionnaire was filled. VAS Pain Scale at 0hr and 1, 2
& 4hrs after dosing were recorded by the subject and
Six-Minute Walk test for effectiveness was measured
by the Investigator. Subjects were provided with patient
diaries. 2000 mg of Acetaminophen for arthritis or other
pain for not more than two days per week and only after
each daily visit was the only concomitant medicine
permitted.