Health Condition 1: M169- Osteoarthritis of hip, unspecified Health Condition 2: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Unstergen Capsules: Dose : 40mg Chicken Collagen
Dosage : One capsule to be consumed once a day
Treatment Duration : 90 days
Route of Administration : Oral
Control Intervention1: Plac
Sponsors
Titan Biotech Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult subject between the ages of 30 and 65 years with confirmed diagnosis or known history of OsteoArthitis (both ages and sexes inclusive) 2. Subjects who have a pain score 5-7 on a 10point NRS at the time of screening in a minimum of one joint . 3. Subjects who are willing to abstain form the use of herbal, allopathic or other nutritional supllements that are indicated at improving osteoarthitis ,Bone health,joint pain. 4. Subjects who are ambulatory requiring but not currently receiving or not satsified with anti -inflammatory or anti analgesic drugs. 5. Subjects who are willing to give infromed consent for participation ,able to comphrend and understand the responsibilites during screening and treatment period. 6. Subject who are willing not to participate in any other clinical trail during participation in the current trail.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to the ingredients of theinvestigational product. 2. Subjects who are on collagen supplements in any form. 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. History of surgery in the target joint. 7. Planned surgery on any lower extremity joint. 8. Clinically significant venous or lymphatic stasis present in the leg(s). 9. Clinically apparent tense effusion or inflammation at the target knee. 10. Any musculoskeletal condition that would impede measurement of efficacy at the target joint. 11. Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product. 12. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study. 13. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc. 14. Subjects on remission from cancer of any type less than 5 years at the time of screening. 15. Subjects who are planning a pregnancy and/or currently breastfeeding. 16. Subjects who have participated in a clinical study less than 1 month before screening. 17. 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. 18. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 19. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. WOMAC: Reduction by greater than equal to 10 total score from baseline 2. Pain NRS Scale : Reduction by greater than equal to 2 scores from baseline 3. Quality of Life Questionnaire : Total score of greater than equal to 15 by end of the study. 4. Global Rating of Change Scales : Score of greater than equal to +2 scores based on improvement in X RAY (Cohort Analysis) Timepoint: 1. WOMAC : Day 1, Day 45,Day 90 2. Pain NRS Scale : Day 1, Day 45,Day 90 3. Quality of Life Questionnaire : Day 45, Day 90 4. Global Rating of Change Scales : Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| None. Not Applicable.Timepoint: None. Not Applicable. | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare R&D India Pvt. Ltd.
Outcome results
None listed