Is the Ayurvedic oil preparation (Kubja prasaranie) effective when compared to a placebo in reducing pain, stiffness, and improving function in the treatment of symptomatic knee osteoarthritis?

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 be blinded to the intervention status.

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 of <7 at the first (B1) and second (B2) baseline visits five days apart.

1. Inflammatory diseases
2. History of total knee replacement
3. Long term use of non-steroidal anti-inflammatory drugs (Patients will be required to withdraw from topical non-steroidal anti-inflammatory drugs for 48 hours prior to recruitment)
4. Serious co-morbidities (e.g. any form of debility that restricts independent movement, stroke, chronic renal failure and inadequate mental capacity to participate in the study)
5. Difference in pain rating (determined from questions of WOMAC) or the difference in the total average pain score between the B1 and B2 over 2.
6. Skin lesions or dermatological diseases in the treatment area
7. Symptomatic ipsilateral hip osteoarthritis or predominant patello-femoral knee osteoarthritis
8. Non-index knee pain, or any other pain condition requiring the chronic use of pain medication
9. Intra-articular injections of hyaluronic acid within 3 months before or during the study
10. Use of oral, inhaled, parenteral corticosteroids within 2 months before or during the study
11. Intra-articular injections of corticosteroids within one month from the study