Clinical trial NCT05369780: Efficacy Evaluation of Hydrolyzed Collagen Peptide on Knees, Hips, and Ankle Pain in Osteoarthritis
Official title: A Multiple-Dose, Randomized, Double-Blinded, Placebo Controlled Trial To Evaluate The Efficacy Of Hydrolyzed Collagen Peptide On Knees, Hips, and Ankle Pains In Adults With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Joint
Lead sponsor: Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.
Sponsor class: INDUSTRY
Collaborators: name: Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.
First posted: 2022-05-11
Enrollment: 160
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Primary outcomes:
measure: Amelioration on Knee Pain
timeFrame: 2 months
Secondary outcomes:
measure: Amelioration on Hip Pain
timeFrame: 2 months
measure: Amelioration on Ankle Pain
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References: