Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Tablet Myostaal forte: One tablet three times daily for 6 months
Control Intervention1: Tablet Glucosamine sulphate: One tablet of 500 mg three times daily for 6 months
Sponsors
Solumiks Herbaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed case of Idiopathic knee osteoarthritis for minimum 6 months and maximum 5 years according to clinical guidelines of American college of Rheumatology. The guidelines include patient currently experiencing pain in one or both the knees with at least 3 out of the following 6 features: - Age 40 â?? 70 years - Morning stiffness within 30 minutes of walking - Crepitus - Bony tenderness - Bony enlargement - No palpable warmth 2. Patient having baseline knee joint pain more than 40 mm on Visual Analogue Scale (VAS) either at rest or on weight bearing activities (e.g. walking, standing, climbing staircase) during the preceding 24 hours. 3. Patients willing to give written informed consent. 4. Patients willing to follow up.
Exclusion criteria
Exclusion criteria: 1. Patient with secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement) 2. Patient on corticosteroid use: (a) oral corticosteroid within the previous 14 days, or (b) intramuscular corticosteroid within 30 days, or (c) intra-articular corticosteroid into the study knee within 90 days, or (d) intra-articular corticosteroid into any other joint within 30 days, or (e) topical corticosteroid at the site of application within 14 days; Or patient requiring systemic corticosteroids during the course of study. 3. Patient who has undergone or who is planning to undergo surgery in next 3 months will be excluded from the study 4. Patient who has underwent knee replacement surgery for the affected knee and who have undergone a knee arthroscopy within past 2 years. Also, Patient with intra-articular visco supplementation (e.g., Synvisc®) in the affected knee joint in the preceding 6 months 5. Patient with on-going use of medication including oral muscle relaxants, or low-dose antidepressant for any chronic pain management 6. Patients with on-going use of glucosamine or chondroitin sulphate or used continuously for 30 days prior to the study entry 7. Patients with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease. 8. Patient with abnormal Hb/CBC values, 10% beyond the normal range will lead to exclusion of the patient from the study. 9. Patient with laboratory parameters of Liver function test more than 1.5 times the upper limit of normal or detected any time during the study period will lead to exclusion of the patient from the study. 10. Patient with Serum Creatinine more than 1.5 mg/dl, detected any time during the study period will lead to exclusion of the patient from the study 11. Patient with history of clinically-active renal, hepatic or peptic ulcer disease 12. History of life threatening cardiovascular and /or neurological event in the past one year. 13. Patient with history of alcohol or drug abuse, bleeding disorder 14. Patient having any severe active infectious disease requiring hospitalization. 15. Pregnancy or lactation. 16. Patient who has taken study drug or any herbal medication in the past 4 weeks. 17. Patient with history of severe allergy or anaphylactic reaction. 18. Patient participating in another investigational drug trial in the previous 30 days. 19. Patients who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness 20. Known history of positive screening result for hepatitis B and/or Hepatitis C virus. 21. History of HIV or any immune deficient conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the significant reduction in the consumption of Tab Paracetamol per patient as an analgesic over a period of 6 months in both the groupsTimepoint: To compare the significant reduction in the consumption of Tab Paracetamol per patient as an analgesic over a period of 6 months in both the groups | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the mean change in Quality of life questionnaire score from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groupsTimepoint: Baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups;To compare the mean change in the Lequesne Impairment score from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation visit in comparison to glucosamine group.Timepoint: Baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation;To compare the mean change radiographic grading score of knee OA from baseline to day 180 or at the final visit at the time of subject discontinuation in both the groupsTimepoint: baseline to day 180 or at the final visit at the time of subject discontinuation in both the groups;To compare the number of patients achieving VAS score 3 from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groupsTimepoint: Baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups;To compare the number of patients showing a change in the WOMAC pain subscales score by at least 2 grades from To compare the number of patients showing a change in the WOMAC pain subscales score by at least 2 grades from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groupsTimepoint: Baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups;To compare the number of patients showing a change in the WOMAC physical function subscales score of 1 from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the gr | — |
Countries
India
Contacts
Public ContactDr Raakhi Tripathi
Seth GS Medical College & KEM Hospital
Outcome results
None listed