Pain, JointNCT05369780
Efficacy Evaluation of Hydrolyzed Collagen Peptide on Knees, Hips, and Ankle Pain in Osteoarthritis
A study testing Hydrolyzed Collagen Peptide in people with Pain, Joint, run by Sel Sanayi Urunleri Ticaret ve Pazarlama A.S..
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Pain, Joint
- What is being tested?
- Hydrolyzed Collagen Peptide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 are not suitable to any of inclusion criteria.
- Who have history of difficulty of swallowing.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Pain, Joint
- Being tested
- Hydrolyzed Collagen Peptide
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed Collagen PeptideDietary supplement
Also called Collagen
Dietary Hydrolized Collagen Peptide sourced from bovine
| Study group | Role | What they receive |
|---|---|---|
| Hydrolized Collagen Peptide | Experimental | This arm will be allocated randomly and receive 10 g hydrolized collagen peptide (Investigational Product) daily throughout the study. Receives: Dietary Supplement: Hydrolyzed Collagen Peptide |
| Placebo | Placebo comparator | This arm will be allocated randomly and receive placebo daily throughout the study. Receives: Dietary Supplement: Hydrolyzed Collagen Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (2)
Amelioration on Hip Pain
Amelioration on pain, stiffness and physical function of joints of hip according to WOMAC score.
Measured: 2 months
Amelioration on Ankle Pain
Amelioration on pain and physical function of ankles according to AOFASAHFS (American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale) scale.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start15 May 2022 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369780
- Sponsor's protocol ID
- ALP-2021-CL-01-2021/01998
- Status last verified
- May 2022
- First submitted
- 6 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40507417
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05369780
- Acronym / sponsor ID
- ALP-2021-CL-01-2021/01998
- Conditions
- Pain, Joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.Industry (pharma, biotech, devices)
- Collaborators
- Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrolized Collagen Peptide | Experimental | Dietary Supplement: Hydrolyzed Collagen PeptideThis arm will be allocated randomly and receive 10 g hydrolized collagen peptide (Investigational Product) daily throughout the study. |
| Placebo | Placebo comparator | Dietary Supplement: Hydrolyzed Collagen PeptideThis arm will be allocated randomly and receive placebo daily throughout the study. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolyzed Collagen PeptideAlso: CollagenDietary Hydrolized Collagen Peptide sourced from bovine | Dietary supplement | Hydrolized Collagen Peptide, Placebo |
Primary outcome
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.
2 secondary outcomes
Amelioration on Hip Pain
Time frame: 2 months
Amelioration on Ankle Pain
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Derived from this study: PubMed 40507417Demir-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolyzed Collagen Peptide in people with Pain, Joint, run by Sel Sanayi Urunleri Ticaret ve Pazarlama A.S..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aydın Erenmemişoğlu, Prof. Dr. (+90 532 551 0082, aydin@alpanfarma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amelioration on Knee Pain (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05369780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.