Knee Osteoarthritis
Conditions
Interventions
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 w
Sponsors
HETC Project, Ministry of Higher Education, Sri Lanka.
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Subjects with non-degenerative joint diseases or other joint diseases such as ?ma v?ta (rheumatoid arthritis), Kazhugazha v?ta, (psoriatic arthritis), Piramega v?ta (gonococcal arthritis), Narithalai v?ta (haemo arthritis) 2. Subjects with severe disabling arthritis and / or bedridden. 3. History of intra-articular knee injection within the month preceding the study 3. Severe unstable renal, hepatic, diabetic, haemopoietic, malignant, hypertensive, cardiac disorder and mentally affected as revealed by history and / or investigation. 4. Subject taking antipyretics, analgesics, tranquilizers, hypnotics, alcohol, or any other drug which would interfere with pain perception and need for other drug therapy for arthritis 5. Women who are pregnant, lactating 6. Those unwilling to come for regular follow-up for the entire duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Traditional clinical parameters {Prakriti assessment, eight fold examination and six fold source of knowledge} [At baseline, 10th, 20th, 30th, 40th days, and on follow-up assessment at the end of one month and two months.] 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. [At baseline, 10th, 20th, 30th, 40th days, and on follow-up assessment at the end of one month and two months.] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. [At baseline and immediately after end of therapy (40th day) then follow-up period at the end of one month and two months.] 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 [At baseline and immediately after end of therapy (40th day) then follow-up period at the end of one month and two months.] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. (Miss) Vinotha Sanmugarajah
Lecturer (Probationary)
Outcome results
None listed