A study to compare the efficacy of topical Ayurvedic oil preparation against placebo in symptomatic knee osteoarthritis

INTERVENTION: Study Setting: outpatient clinics of National Ayurveda Hospital, Rajagiriya, Sri Lanka. This study is designed as a double blinded randomized controlled crossover trial. Targeted study population is patients with symptomatic knee osteoarthritis undergoing acupuncture therapy, attending outpatient clinics of National Ayurveda Hospital, Rajagiriya, Consecutive patients fulfilling selection criteria would be recruited into the study. Study participants would be divided into two groups randomly using computer generated numbers. Interventional product: The ingredients of our Ayurvedic oil preparation, Kubja prasaranie are as follows. Prasarani (Paederiafoetida), rathnithul (Plumbegoindica), valmi (Glycyhizaglabra), wadakaha (Acrouscalamus),shatapushpa (Anethumsowa), devadara (Cedrusdeodara), aratta (Alpinia calcarata), gajatippli (Scindapsus officinalis), Jatamansha (Nardostahys jatamansi) bhallathska (Semecarpus anacardium).The base of the oil is made with sesame oil, cow milk, kaadi (vinegar).The Ayurvedic oil is prepared according to standard Ayurvedic texts. Two randomized groups will receive a placebo oil (prepared from virgin coconut oil) or the medicinal oil preparation for a period of 4 weeks. After a washout period of 4 weeks, the same subjects will crossover to receive the other compound. In keeping with current Ayurvedic practices both groups of patients will be instructed to apply the Ayurvedic oil and the placebo oil separately to the intact skin on both side of the knee and the popliteal fossa, but to avoid the patella. They will be requested to apply the oil 10 ml at time, twice a day for a total of 4 weeks. The oil should be left for a minimum of one hour after application. All other management will be provided equally to both arms according to standard protocols at the institute. Participants, health care workers, data collectors and data analysts will CONDITION: Knee Osteoarthritis PRIMARY OUTCOME: 1. Reduction of pain; 2. Reduction of functional limitation; 3. Reduction in stiffness ; ; The outcomes will be assessed using the Western Ontario and McMaster Universities (WOMAC) composite index. INCLUSION CRITERIA: 1. Diagnosis of symptomatic knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) radiological and clinical criteria, with a functional scale between i – iii. 2. Radiographic evidence of knee osteoarthritis (osteophytes, joint space narrowing) 3. Knee pain (3‐4 pain flares per month) along with three out of the following six a. Age >50 years and <70 years b. Joint stiffness lasting for less than 30 minutes c. Joint crepitus d. Bony tenderness e. Bony enlargement f. No palpable warmth 4. Ability to identify a predominantly painful (index) knee with moderate pain in the index knee, defined by pain on walking on a flat surface, pain at rest and climbing upstairs rated as 4 or 5 for questions of the the Western Ontario and McMaster Universities Arthritis Index [WOMAC ‐ 11 point numerical rating scale (NRS), v. 3.1] and a total average WOMAC pain sub scale score