A clinical study to assess the effect of a Unani formulation in the gel form and medicated steam form in patients of Knee Osteoarthritis

INTERVENTION: Intervention1: Unani formulation: the intervention will be the Unani formulation, in the form of gel to be locally applied on Knee joint in the patients of Knee OA, twice daily for one month. Control Intervention1: Bukhoor (Medicated steam of unani drugs): the comparator will be the Unani formulation, in the form of medicated steam (Bukhoor)to be locally applied on Knee joint in the patients of Knee OA for one month. CONDITION: Health Condition 1: M179‐ Osteoarthritis of knee, unspecified Health Condition 2: M179‐ Osteoarthritis of knee, unspecified PRIMARY OUTCOME: Visual Analogue Scale (VAS) for pain. ; KOOS (Knee injury and OA outcome score) for pain, stiffness, functions in daily living, function in sports and recreational activities, quality of life and other symptoms. ; 4‐Point Likert Scale (0‐3) for joint tenderness. ; Knee circumference for swelling of knee joint. ; Range of movements (ROM). ; Timepoint: Baseline, Ist Wk, 2nd wk, 3rd wk, 4th wk and 5th wk (treatment free wk). SECONDARY OUTCOME: Response of patient to the therapy on a 5‐point Likert Scale (0‐4) by patientâ??s Global Assessment (PGA). ; Response of investigator to the therapy on a 5‐point Likert Scale (0‐4) Investigatorâ??s Global Assessment (IGA). ; SF‐12 for quality‐of‐life assessment. ; Timepoint: 4 weeks INCLUSION CRITERIA: â?¢ Patients of Knee OA according to American College of Rheumatology (ACR) criteria Clinical classification criteria plus radiographic findings (X‐ray) for knee osteoarthritis. 1.Pain in for most days of the prior month and â??oneâ?? of the following three ï?¼ Morning stiffness â?¤30 minutes duration. ï?¼ Age 40 to 65 years. ï?¼ Crepitus on active knee movement 2.Presence of Osteophytes on knee Radiograph. â?¢ Patients with pain intensity score of 3 cm or more on a 10 cm visual analog scale (VAS). â?¢ Willingness and ability to accept intervention and to comply with the requirements of the protocol.