Study of the combination of amukkirai chooranam with thalangai ennai and vellarugu chooranam with thalangai ennai in the treatment of knee osteoarthritis

INTERVENTION: Patients will be recruited for the trial following qualitative and quantitative analysis of the trial medicines (Amukkirai and Vellarugu chooranam) and a pilot study. Subjects for the clinical trial will be selected from Out Patients Department (O.P.D.) and Indoor Patients Department (I.P.D.) of Ayurvedic Hospitals / Dispensaries in Jaffna District. Eligible patients with knee osteoarthritis will be randomized in a 1:1 ratio to the treatment arms. The prescribed dose is two capsules thrice a day with lukewarm water after meals. The daily dose of experimental medicine is 3g (Each capsule contains 500mg of trial plant materials) and local applications of oil {10ml} twice a day for one mandalam (40 days). Subjects will be requested to refrain from other alternative medicinal therapy (allopathic, homeopathy, acupuncture, and acupressure, etc.) during the study period. CONDITION: Knee Osteoarthritis PRIMARY OUTCOME: 1.Traditional clinical parameters {Prakriti assessment, eight fold examination and six fold source of knowledge}; ; 2.Clinical parameters: gait, knee joint pain {Visual Analogue Scale (VAS)}, stiffness, tenderness on knee joint, knee joint swelling, muscular wasting (a tape measure), local crepitation, walking time, restriction of knee joint movement, range of knee joint movements (Goniometer assessment), knee joint deformities and muscular power. SECONDARY OUTCOME: 1. The effect of morbidity status on health related quality of life in subjects will be measured by the WOMAC questionnaire, goniomter assessment and Visual analogue Scale. Questionnaire will be used to assess pain, stiffness and physical functions depending on score basis. Movements and pain will be measured by goniometer and VAS scale respectively. ; ; 2. Routine laboratory workup (haemoglobin, White blood cell ‐ total and differential count, Erythrocyte sedimentation rate, Rheumatoid factor assays, Liver function test and Kidney function test} and X‐rays of knees INCLUSION CRITERIA: 1. Subjects suffering from knee osteoarthritis diagnosed based on history, clinical examination findings and classical radiological findings, and fulfilling the American College of Rheumatology (ACR) classification criteria 2. Age above 40 years 3. Pain visual analogue score (VAS) > 4 in one or both the knees while performing a weight bearing activity 4. Ambulant and require analgesic for pain relief and / or not satisfied with ongoing analgesic drugs and seeking a change