Efficacy Evaluation of Hydrolyzed Collagen Peptide on Knees, Hips, and Ankle Pain in Osteoarthritis

Launched by SEL SANAYI URUNLERI TICARET VE PAZARLAMA A.S. · May 6, 2022

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female individuals with osteoarthritis on knee who are aged between 45-60 years old,
• • 2. Who are not drug-naïve to osteoarthritis and related conditions,
• • 3. Volunteers who have ability to communicate adequately with the investigator and in agreement to comply with the study requirements,
• • 4. Volunteers who have normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 100 bpm at least after 5 minutes of rest,
• • 5. Volunteers who have understanding of the study and agreement to give a written informed consent.
• Exclusion Criteria:
• • 1. Who have atopic constitution or asthma and/or known allergy for bovine derived collagen products and/or other any of the excipients of the product.
• • 2. Who have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
• • 3. Who have an active rheumatoid arthritis or any other inflammatory arthritic condition that researchers consider non appropriate.
• • 4. Who have Diabetes Mellitus.
• • 5. Who have the use of oral retinoids or oral steroids in the 6 months prior to initiation of the study.
• • 6. Who have current participation in another clinical study, or participation in a relevant study within 3 months.
• • 7. Who have any history or presence of serious or life-threatening conditions of cardiovascular, neurological, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphiria.
• • 8. Who have the presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
• • 9. Who are planned to go or already went under a joint-related reconstructive surgery,
• • 10. For female volunteers, who had undergone, or planned to undergo, pregnancy or breastfeeding.
• • 11. Who have current or regular intake of NSAIDS, contraceptives, hormones, obesity drugs, absorption inhibitors or antidepressants
• • 12. Who are suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgment.
• • 13. Who have history of drug abuse.
• • 14. Who have relationship to the investigator.
• • 15. Who are not suitable to any of inclusion criteria.
• • 16. Who have history of difficulty of swallowing.