The present study will be conducted in India after IEC approval. Diagnosis of OA of knee will be confirmed by radiographs and diagnosed according to ACR diagnostic criteria.  Subject will then undergo investigations i.e. fasting blood sugar, CBC, ESR, Hb%, Liver function tests, Renal function tests, Lipid profile, Urine routine and microscopic, Urine pregnancy test (only if the subject is female of child bearing potential), HIV test [every patient (for screening) will be sent to ICTC of Saneguruji Aarogya Kendra for pre investigation counseling. The consent form will also be signed at ICTC and the photocopy of the same will be enclosed in the CRF] and ECG.

A wash out period of 7 days will be given. During washout period and the whole study period (viz. 90 days + 7 days), subject will be advised to refrain from NSAID’S or any other local or systemic analgesics and steroids, except tab Paracetamol (up to 2 gm/day in case of severe joint pain) or any standard analgesic drug. Also subject will be advised to refrain from any Ayurvedic, Homeopathy, Unani, Siddha Medicine, and Nutraceutical and food supplements for OA of Knee.

On baseline visit (Day 0), subjects will be recruited if he/she meets all the inclusion criteria. Subjects will then undergo general and systemic examinations. Subject’s baseline knee joint(s) pain will be assessed on Visual Analogue Scale (VAS), subjects joint pain subscore, stiffness subscore and physical function subscore will be assessed on WOMAC Index. The knee(s) will be evaluated for soft tissue swelling/synovitis (grade: 0= None, 1= Mild, 2=Moderate, 3=Severe.) All the subjects will be evaluated for their quality of life on SF -36 questionnaires.  Subjects will be asked to walk 50 feet on flat surface and the time required to walk 50 feet and distance between feet while walking 50 feet on even surface will be recorded in the CRF.

 Subjects will be given 1 HDPE container (60 tablets) of Ostofix Tablet. All the subjects will be advised to take 2 tablets of given Ostofix twice daily orally after meals for 90 days. After the baseline visit, subjects will be called for follow up visits on 15^th day, 30^th day, 45^th day, 60^th day, 75^th day and 90^th day

On every follow up visit except last follow up visit, subjects will be provided with study medicine. On every follow up visit, the empty container will be collected from the subject and drug compliance will be checked.

 During study period, subjects will be allowed to take tab Paracetamol up to 2 gm/day or any standard analgesic drug in case of severe joint pain. The use of Paracetamol or any standard analgesic drug as a rescue medicine will be recorded in the CRF.

On every follow up visit, subjects will undergo general and systemic examinations. The Knee joint(s) pain will be assessed on Visual Analogue Scale (VAS).  Subject’s knee joint(s) pain subscore, stiffness subscore and physical function subscore will be assessed on WOMAC Index. The knee(s) will be evaluated for soft tissue swelling/synovitis. Patient’s global evaluation and Investigator’s global evaluation for overall improvement will be done on last follow up visit. On day 30, day 60 and day 90, all the subjects will be evaluated for their quality of life on SF -36 questionnaires. Subjects will be asked to walk 50 feet on flat surface and the time required to walk 50 feet and distance between feet while walking 50 feet on even surface will be recorded in the CRF. Tolerability of the trial medicines will be assessed by the investigator and by the subject at the end of study. All the subjects will be closely monitored for any adverse events/ adverse drug reactions.

On final follow up visit (i.e. Day 90), subject’s laboratory investigations (viz. CBC, ESR, Hb%, Liver function tests, Renal function tests, Lipid profile, Urine routine & microscopic) will be performed. After completion of 90 days of study treatment, all the subjects will be asked to stop trial medications and take advice of investigator for further treatment.