Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Collagen Peptide (fish): 10g of product to be dissolved in warm water and consumed once a day, for 90 days
Intervention2: Collagen Peptide (Bovine): 10g of product to be dissolved in wa
Sponsors
Titan Biotech Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults between 30 and 65 years of age with confirmed diagnosis or known history of OsteoArthritis, with moderately active lifestyle.(both ages and all sexes inclusive) 2. Subject with Grade II or III of Kellergen Lawrence (KL) Grade. 3. Subject with pain (VAS score >=4) on walking in one or both knees 24 hours prior to screening. 4. Subjects with BMI 5. Subjects who are ambulatory, requiring but not currently receiving or not satisfied with anti-inflammatory or anti-analgesic drugs. 6. Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period. 7. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to investigational product or its constituents. 2. Subjects with known hypersensitivity to NSAID, aspirin, COX-2 inhibitors and other analgesic medicine. 3. Subjects who have had hyaluronic acid injections, upto 6 months prior to enrolment. 4. Subjects who have had Intra-Articular Steroid, upto 3 months prior to enrolment. 5. Subjects with immunucompromised state complications. 6. Significant (requiring surgical correction) valgus or varus deformity of the knee, ligamentous laxity, or meniscal instability. 7. Concomitant inflammatory or any other disease/condition which may affect joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis etc.). 8. History of sepsis in any joint or any clinical concern for a sub-acute infectious process in the target joint. 9. History of surgery in the target joint. 10. Planned surgery on any lower extremity joint. 11. Clinically significant venous or lymphatic stasis present in the leg(s). 12. Clinically apparent tense effusion or inflammation at the target knee. 13. Any musculoskeletal condition that would impede measurement of efficacy at the target joint 14. Subjects with uncontrolled diabetes, hypertension or congestive heart failure. 15. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation. 16. Females who are pregnant or lactating or planning to become pregnant during the study period. 17. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 18. Subjects, who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. WOMAC Scale: Reduction by â?¥15 scores by end of treatment period. 2. Visual Analogue Scale: Reduction by â?¥3 scores by end of treatment period. 3. Quality of life Questionnaire: Improvement by â?¥10 scores by end of treatment period. 4. Clinical Global Impression Scale based on X Ray Impression: Score of â?¤3 by end of treatment Timepoint: 1. WOMAC Scale: Day 1, Day 45, Day 90 2. Visual Analogue Scale: Day 1, Day 45, Day 90 3. Quality of life Questionnaire: Day 1, Day 45, Day 90 4. Clinical Global Impression Scale based on X Ray Impression: Day 1, Day 45, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare R & D India Private Limited
Outcome results
None listed