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

Phase 2

Conditions: Health Condition 1: M179- Osteoarthritis of knee, unspecifiedHealth Condition 2: M179- Osteoarthritis of knee, unspecified

Recruitment & Eligibility

Inclusion Criteria

• 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 <=30 minutes duration.

ï?¼ Age 40 to 65 years.

ï?¼ Crepitus on active knee movement

2.Presence of Osteophytes on knee Radiograph.

• Patients with pain intensity score of 3 cm or

more on a 10 cm visual analog scale (VAS).

• Willingness and ability to accept intervention and to comply with the requirements of the protocol.

Exclusion Criteria

Ã? Pregnant and lactating females.

Ã? Severely ill patients.

Ã? History of significant trauma, infection or

presence of hematoma at the site of knee and/or

knee surgery.

Ã? History of other musculoskeletal disorders.

Ã? Known case of malignancy.

Ã? Patients taking NSAIDâ??s and corticosteroids, (a

wash out period of 1week and 4 weeks

respectively is required before enrolling

patient).

Ã? Unwilling to participate in the study.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) for pain. <br/ ><br>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. <br/ ><br>4-Point Likert Scale (0-3) for joint tenderness. <br/ ><br>Knee circumference for swelling of knee joint. <br/ ><br>Range of movements (ROM). <br/ ><br>Timepoint: Baseline, Ist Wk, 2nd wk, 3rd wk, 4th wk and 5th wk (treatment free wk).

Secondary Outcome Measures

Name	Time	Method
Response of patient to the therapy on a 5-point Likert Scale (0-4) by patientâ??s Global Assessment (PGA). <br/ ><br>Response of investigator to the therapy on a 5-point Likert Scale (0-4) Investigatorâ??s Global Assessment (IGA). <br/ ><br>SF-12 for quality-of-life assessment. <br/ ><br>Timepoint: 4 weeks