Efficacy Evaluation of Hydrolyzed Collagen Peptide on Knees, Hips, and Ankle Pain in Osteoarthritis
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
1 other identifier
interventional
160
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2022
CompletedFirst Posted
Study publicly available on registry
May 11, 2022
CompletedStudy Start
First participant enrolled
May 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2023
CompletedMay 11, 2022
May 1, 2022
1 year
May 6, 2022
May 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Amelioration on Knee Pain
Amelioration on knee joint pain, stiffness and physical function according to WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score.
2 months
Secondary Outcomes (2)
Amelioration on Hip Pain
2 months
Amelioration on Ankle Pain
2 months
Study Arms (2)
Hydrolized Collagen Peptide
EXPERIMENTALThis arm will be allocated randomly and receive 10 g hydrolized collagen peptide (Investigational Product) daily throughout the study.
Placebo
PLACEBO COMPARATORThis arm will be allocated randomly and receive placebo daily throughout the study.
Interventions
Dietary Hydrolized Collagen Peptide sourced from bovine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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 procedure and/or completion of the study according to the investigator's judgment.
- Who have history of drug abuse.
- Who have relationship to the investigator.
- Who have history of difficulty of swallowing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Demir-Dora D, Tuna S, Kurtoglu ED, Gursoy S, Balci N, Tezman S, Erenmemisoglu A. Evaluation of the Efficacy and Safety of CollaSel PRO(R) Type I and Type III Hydrolyzed Collagen Peptides in the Treatment of Osteoarthritis: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Clin Med. 2025 May 23;14(11):3655. doi: 10.3390/jcm14113655.
PMID: 40507417DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2022
First Posted
May 11, 2022
Study Start
May 15, 2022
Primary Completion
May 15, 2023
Study Completion
May 15, 2023
Last Updated
May 11, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share