Last updated: May 6, 2022
Sponsor: Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Muscle Pain
Arthritis And Arthritic Pain
Osteoarthritis
Treatment
N/AClinical Study ID
NCT05369780
ALP-2021-CL-01-2021/01998
Ages 45-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and female individuals with osteoarthritis on knee who are aged between 45-60years old,
- Who are not drug-naïve to osteoarthritis and related conditions,
- Volunteers who have ability to communicate adequately with the investigator and inagreement to comply with the study requirements,
- Volunteers who have normal blood pressure and heart rate measured under stabilisedconditions at the screening visit after at least 5 minutes of rest under supineposition: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 100bpm at least after 5 minutes of rest,
- Volunteers who have understanding of the study and agreement to give a writteninformed consent.
Exclusion
Exclusion Criteria:
- Who have atopic constitution or asthma and/or known allergy for bovine derivedcollagen products and/or other any of the excipients of the product.
- Who have hereditary problems of galactose intolerance, the Lapp lactase deficiency orglucosegalactose malabsorption.
- Who have an active rheumatoid arthritis or any other inflammatory arthritic conditionthat researchers consider non appropriate.
- Who have Diabetes Mellitus.
- Who have the use of oral retinoids or oral steroids in the 6 months prior toinitiation of the study.
- Who have current participation in another clinical study, or participation in arelevant study within 3 months.
- Who have any history or presence of serious or life-threatening conditions ofcardiovascular, neurological, haematological, hepatic, gastrointestinal, renal,pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphiria.
- Who have the presence or history of malabsorption or any gastrointestinal surgeryexcept appendectomy or except herniotomy.
- Who are planned to go or already went under a joint-related reconstructive surgery,
- For female volunteers, who had undergone, or planned to undergo, pregnancy orbreastfeeding.
- Who have current or regular intake of NSAIDS, contraceptives, hormones, obesity drugs,absorption inhibitors or antidepressants
- Who are suspected to have a high probability of non-compliance to the study procedureand/or completion of the study according to the investigator's judgment.
- Who have history of drug abuse.
- Who have relationship to the investigator.
- Who are not suitable to any of inclusion criteria.
- Who have history of difficulty of swallowing.
Study Design
Total Participants: 160
Study Start date:
May 15, 2022
Estimated Completion Date:
May 15, 2023