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

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/A

Clinical Study ID

NCT05369780
ALP-2021-CL-01-2021/01998
  • Ages 45-60
  • All Genders

Study Summary

The aim of this study is to evaluate the effectiveness of Hydrolyzed collagen peptides on joint pain, stiffness and physical function in adults with osteoarthritis who have complaints on knee joints together with hip and ankles. The assessment of improvements on volunteers' quality of life, and safety and tolerability of the product is the other objective of this placebo-controlled, randomized study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female individuals with osteoarthritis on knee who are aged between 45-60years old,
  2. Who are not drug-naïve to osteoarthritis and related conditions,
  3. Volunteers who have ability to communicate adequately with the investigator and inagreement to comply with the study requirements,
  4. 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,
  5. Volunteers who have understanding of the study and agreement to give a writteninformed consent.

Exclusion

Exclusion Criteria:

  1. Who have atopic constitution or asthma and/or known allergy for bovine derivedcollagen products and/or other any of the excipients of the product.
  2. Who have hereditary problems of galactose intolerance, the Lapp lactase deficiency orglucosegalactose malabsorption.
  3. Who have an active rheumatoid arthritis or any other inflammatory arthritic conditionthat 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 toinitiation of the study.
  6. Who have current participation in another clinical study, or participation in arelevant study within 3 months.
  7. 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.
  8. Who have the presence or history of malabsorption or any gastrointestinal surgeryexcept 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 orbreastfeeding.
  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 procedureand/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.

Study Design

Total Participants: 160
Study Start date:
May 15, 2022
Estimated Completion Date:
May 15, 2023