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

Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.0 sites160 target enrollmentMay 15, 2022

ConditionsPain, Joint

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pain, Joint
Sponsor: Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.
Enrollment: 160
Primary Endpoint: Amelioration on Knee Pain
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 15, 2022

End Date

May 15, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female individuals with osteoarthritis on knee who are aged between 45-60 years old,
•Who are not drug-naïve to osteoarthritis and related conditions,
•Volunteers who have ability to communicate adequately with the investigator and in agreement to comply with the study requirements,
•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,
•Volunteers who have understanding of the study and agreement to give a written informed consent.

Exclusion Criteria

•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.
•Who have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
•Who have an active rheumatoid arthritis or any other inflammatory arthritic condition that researchers consider non appropriate.
•Who have Diabetes Mellitus.
•Who have the use of oral retinoids or oral steroids in the 6 months prior to initiation of the study.
•Who have current participation in another clinical study, or participation in a relevant study within 3 months.
•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.
•Who have the presence or history of malabsorption or any gastrointestinal surgery except 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 or breastfeeding.

Outcomes

Primary Outcomes

Amelioration on Knee Pain

Time Frame: 2 months

Amelioration on knee joint pain, stiffness and physical function according to WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score.