Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: myrlimax capsule 100mg: Nutraceuticals, two capsules daily in morning and evening after breakfast for 30 days
Control Intervention1: ETORICOXIB: it used for pain reliving agent
Control
Sponsors
VIGNANS FOUNDATION OF SCIENCE, TECHNOLOGY AND RESEARCH
Aditya Research Center
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosis of arthritis rheumatoid arthritis 2. osteoarthritis gout arthritis based on history clinical presentation and radiological findings 3. Minimum VAS 4 on walking in one or both hands or knee during 24 hours preceding requirement 4. Patient ambulant and requiring treatment for arthritis 5. Post operative patients are also eligible 6. Willing to come for regular follow up visits 7. Able to give written informed consent form
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity to herbal extracts or dietary supplements. 2. Pregnant women, lactating women and women of childbearing potential not following adequate contraceptive measure, women who were found to positive for urine pregnancy test. 3. Patient incapacitated or bound to wheelchair or bed and unable to carryout self- care activities. 4. Treatment with intra- articular injection of corticosteroids into knee within 3 months preceding study. 5. Pre- existing or recent onset of demyelinating disorders or type I diabetes. 6. Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicine. 7. Evidence of serval renal, hepatic or hemopoietic disease or severe cardiac insufficiency as revealed by laboratory investigations. 8. Patient with congestive heart failure. 9. Patient with hypertension 10. Clinically significant untreated hyper-lipidaemia in context of cardiovascular risk 11. History of having received any investigational drug or participated in any other clinical trial which ended in preceding month or currently ongoing. 12. Ayurvedic formulation or any form of CAM (complimentary alternative medicine) therapy in the preceding 2 months. 13. Non- co- operative attitude of patients 14. Any condition that in the opinion of the investigator does not justify the patientâ??s inclusion for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of Commiphora myrrha (Myrlimax capsule) with etoricoxib in managing the patients with painful arthritis. change from baseline to end of the study in scores in simple reaction time Timepoint: Mean change in WOMAC â?? total score (Day 0, day 15 and Day 30) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in WOMAC â?? pain subscale. 2. Mean change in WOMAC â?? stiffness subscale. 3. Mean change in WOMAC â?? function subscale. 4. Mean change in VAS pain scale. 5. Mean change in distance walked in 6 minutes. 6. Mean change in European Q5D quality of life. 7. Mean change in biomarker (Hs-CRP, ESR, collagen specific binding antibody count, TNF- alpha, IL1-beta and IL-6). 8. Safety assessment through laboratory test. 9. Mean change in physicianâ??s global assessment. 10. Mean change in the radiological parameters. 11. Safety assessment through change in vital sign, physical examination, adverse events. 12. Mean change in WOMAC â?? total score fore residual effect. 13. Mean scale change in VAS pain scale for residual effect Timepoint: 1. Day 0, day 15 and day 30. 2. Day 0, day 15, day 30. 3. day 0, day 15, day 30. 4. screening day, day 15, day 30. 5. day 0, day 15, day 30. 6. day 0, day 30. 7. day 0 and day 30. 8. day 0, day 30. 9. screening day, day 15 day 30. 10. screening, day 15 and day 30. 11. day 0, day 15 day 30. 12. day 30 and day 45. 13. day 30 and day 45 | — |
Countries
India
Contacts
Public ContactDr Komaragiri krishna
Vignans Foundation for Science Technology and Research
Outcome results
None listed