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Randomized controlled trial
Targeted patients who come to receive treatment for osteoarthritis that meets the research indications will be assigned to a random group by the box of 4 randomization method, with a sequence that is randomly generated by a computer. The groups are divided into two groups:
Group 1: Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen
Group 2: Control patients will take placebo
Primary outcome : Pain level
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen supplement group | Experimental | Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) 2 tabs a day |
|
| Control group | Placebo Comparator | Control patients will take placebo 2 tabs a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen | Dietary Supplement | Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) 2 tabs a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain (VNRS) | Pain level (verbal numerical rating scale :VNRS) - 0 is no pain and 10 is the worst pain | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Knee and Osteoarthritis Outcome Score (KOOS) | Knee and Osteoarthritis Outcome Score (KOOS) - 100 indicates the best possible results and 0 the worst outcome | 12 weeks |
| Rescue medication | Amount of pain medication intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Songkla University | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40897777 | Derived | Yuenyongviwat V, Anusitviwat C, Tuntarattanapong P, Hongnaparak T, Iamthanaporn K. Efficacy of combined undenatured type II collagen and hydrolysed collagen supplementation in knee osteoarthritis: a randomised controlled trial. Sci Rep. 2025 Sep 2;15(1):32313. doi: 10.1038/s41598-025-17505-0. |
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Data will become available and for 1 year after publication.
Open Science Framework (OSF)
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D003094 | Collagen |
| ID | Term |
|---|---|
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D016326 | Extracellular Matrix Proteins |
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| Placebo | Other | Control patients will take placebo 2 tabs a day. |
|
| 12 weeks |
| Patient satisfaction | Patient satisfaction (verbal numerical rating scale :VNRS) - (0-10; 0=worst and 10=best) | 12 weeks |
| D012596 |
| Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |