Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: Type II undenatured collagen 40mg: Nutraceuticals,
Dose 40mg, two capsules daily in morning and evening (BID) after breakfast for 30 days
Control Intervention1: Etoricoxib 90mg: Drug, E
Sponsors
vignans foundation for science, technology, and research
Aditya Research Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient with either sex, 40 to 75 years of age. 2. Diagnosis of arthritis (rheumatoid arthritis, osteoarthritis, gout arthritis) based on history, clinical presentation and radiological findings. 3. Minimum VAS 4 on walking in one or both hands or knee for 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 selfcare activities. 4. Treatment with intra articular injection of corticosteroids into knee within 3 months preceding study. 5. Preexisting 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 hyperlipidaemia 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 cooperative attitude of patients 14. Any condition that in the opinion of the investigator does not justify the patient s inclusion for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of type II Undenatured collagen with etoricoxib in managing the patients with painful arthritis. changes from baseline to end of the study in scores in simple reaction timeTimepoint: Day 0, Day 15, Day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in WOMAC-pain subscale 2. Mean change in WOMAC- stiffness scale 3. Mean change in WOMAC - Function scale 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 biomarkers (HS-CRP, ESR, Collagen specific antibody count, TNF-alpha, IL-1 beta and IL-6 8. Safety assessment through laboratory test 9. Mean change in physician global assessment 10. Mean change in the radiological parameters 11. Safety assessment through changes in vital sign, physical examination, adverse effects 12. Mean change in WOMAC- total score for residual efficacy 13. Mean scale change in VAS pain scale for residual effectsTimepoint: 1. Day 0, day 15, 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, day 30 8. Day 0, day 30 9. Screening day, day 15, day 30 10. Screening day, day 15, day 30 11. Day 0, day 15, day 30 12. Day 30, day 45 13. Day 30, day 45 | — |
Countries
India
Contacts
Public ContactDr Komaragiri krishna
vignans Foundation for Science Technology and Research
Outcome results
None listed