Osteoarthritis is the second most common rheumatic problem and it is the most frequent joint disease with a prevalence of 22%to 39% in India. OA is more common in women than men,but the prevalence increases with age .Nearly,45% of women over the age of 65 year have symptoms while radio logical evidence is found in 70% of those over 65 years. OA was estimated to be the 10^th leading cause of nonfatal burden. OA of the knee is more prevalent as per the literature available. Therefore for finding the current burden of OA it is essential to undertake such clinical study.Although various treatment modalities are available in conventional system of medicine ,but  have got some limitations with serious complications such as gastrointestinal toxicity and ulcers.

In Unani system of medicine the basic pathology of the disease is the accumulation of morbid matter due to weakness of the joint. The weakness of the particular joint is  either primarily due to su-e- mizaj(Impaired Temperament) or secondary to injury or heavy work. The general principal of management is Tadeel-e-sueMizaj(Moderation of abnormal temperament), evacuation of Khilte Ghaleez(Morbid Matter) and Taqwiyat.As far as the treatment of Waja’al- Mafasil is concerned the unani physicians have successfully managed this disease since ancient time by adopting various treatment modalities for evacuating the khilte ghaleez (morbid matter) which is achieved by Munzij -Mushil therapy.For this purpose they used lots of single drug in decoction form such as Aslussoos, Suranjan, Bozidan, Reesha Khatmi, Anisoon, Badranjboya, Sana, Turbud, etc.

For local application they used mucilagenous drugs having hot temperament (Hulba & Alsee) in the form of Dimad (Poultice) & Roghan such as Roghane Arand, Roghane Qust, Roghane Sumbul.They also used a number of regimes such as Fasd (venesection), Hijama (Cupping), Dalk (Massage) and Riyadat (Exercise) .

The primary goal of treatment in  OA is to relieve discomfort by controlling symptoms and signs.For this purpose a unani formulation containing Suranjan sheerin, Bozidan, Anisoon, Filfil Siyah, Zanjabeel in oral form whereas Araq-e- Ajeeb in local form will be used to the participants.These formulations possess Musakkin-al-waja(Analgesic), Muaddil-e-dum (Blood alterative), Muhallil(Resolvent), Muqawwi asab (Nervine tonic) etc but their efficacy and safety has yet to be proved on the basis of scientific parameters.

Keeping the above facts in views,it has been planned to conduct a clinical trial entitled “ A Clinical study to evaluate the efficacy & safety of Unani formulation in the management of  Waja’al-rakba (Knee OA).”