Comparing the efficacy and safety of Sri Lankan traditional medicine regimen for knee osteoarthritis

INTERVENTION: This will be a two‐arm open‐label non‐inferiority randomized control trial in patients with knee osteoarthritis. A consecutive consenting sample method will be followed to select participants of the arms for the study. A blocked design will be used, using an online statistical computing web programming to generate the randomization schedule (research randomizer https://www.randomizer.org). Eligible subjects will be randomly assigned to either Arm I or Arm II The patients of the Arm I will be treated with herbal decoction (Rasnadvigunabhagasya or Maharasnadi decoction) 120 ml twice a day before meals for 50 days, herbal pill ( Yogaraja Guggulu) 1000 gms twice a day before meals for 50 days, herbal paste (Sandivadam Lepaya) sufficient amount for knee daily for 30 days and herbal fomentation (Kumburuetaperumkayam Pottani) daily for 30 days. The patients of Arm II will receive hot water fomentation after applying 1% Diclofenac sodium gel daily for 30 days and Tablet Paracetamol 500 mg twice daily after meals for 60 days and Tablet Ibuprofen 200 mg twice daily after meals for 60 days. Patients in both arms will be asked to visit the clinic twice weekly. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) of the patients will be the primary efficacy endpoint after 12 weeks. The 10 point improvement will be compared between the two arms as the primary endpoint at the end of 2 months of the treatment at the follow‐up visits. WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a quality‐of‐life index will be used as secondary endpoints in the clinical trial. These symptom scores will be analyzed by using the info CONDITION: Knee osteoarthritis ; Musculoskeletal Diseases ; Osteoarthritis of knee PRIMARY OUTCOME: Knee symptoms and function measured using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, 12 weeks, and 4 and 5 months SECONDARY OUTCOME: ; 1. Knee pain, function, and stiffness measured using WOMAC subscales at baseline, 12 weeks, and 4 and 5 months; 2. Impact of knee pain measured using the pain disability index at baseline, 12 weeks, and 4 and 5 months; 3. Pain measured using a visual analog scale (VAS) at baseline, 12 weeks, and 4 and 5 months; 4. Sleep quality measured using a visual analog scale (VAS) at baseline, 12 weeks, and 4 and 5 months; 5. Quality of life measured using the quality‐of‐life index at baseline, 12 weeks, and 4 and 5 months; INCLUSION CRITERIA: Diagnosis and classification of knee osteoarthritis (KOA) based on history, clinical examination findings, and classical radiological findings as follows: 1. The three American College of Rheumatology (ACR) classification criteria for the knee shown below, but for this study the lower age limit will be reduced from 50 years to 40 years: 1.1. ACR Clinical classification criteria, where KOA is classified by the presence of knee pain along with at least three of the following six items: 1.1.1. Aged >50 years 1.1.2. Morning stiffness <30 min 1.1.3. Crepitus on knee motion 1.1.4. Bony tenderness 1.1.5. Bony enlargement 1.1.6. No palpable warmth 1.2. ACR Clinical/Radiographic classification criteria, where KOA is classified by the presence of knee pain with at least one of the followi