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New treatment option for Osteearthritis
Official title Effect of Agar/Collagen-based Compounds on Osteoarticular Pain: Randomized Triple-blind Clinical Trial
ClinicalTrials.gov ID: NCT07318896
What this study is testing
- What it's testing
- Joints-comprising bone, cartilage, ligaments, and synovial fluid-enable stable daily movement but may deteriorate with age, excess body weight, overuse, injury, or disease. Such degeneration, common from age 40 onward, underlies joint disorders like osteoarthritis, particularly in the knees, hips, hands, and spine, and is a major cause of chronic pain and disability.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70
You may be able to join if
- Men and women between 40 and 70 years of age.
- Submit a score of 6 to 10 out of 20 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain questionnaire.
- Sign the informed consent form.
- Know how to read, write, and speak Spanish and/or Catalan.
You likely can't join if
- Present body mass index (BMI) values \<18.5 kg/m\^2 or ≥30 kg/m\^2.
- Present intolerances or allergies related to Agar-Agar, or any of the components of the products being evaluated, such as collagen or maltodextrin.
- Take or have taken medications that may affect the study results. This is especially true for those who have been treated with oral or...
- Patients who depend on prescription medications for pain control.
- Take multivitamin or mineral supplements, collagen derivatives, or supplements containing bioactive compounds that may exert an anti-inflammatory...
- Be an active smoker or have been one for less than 6 months.
See the full eligibility criteria
- Men and women between 40 and 70 years of age.
- Submit a score of 6 to 10 out of 20 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain questionnaire.
- Sign the informed consent form.
- Know how to read, write, and speak Spanish and/or Catalan.
- Present body mass index (BMI) values \<18.5 kg/m\^2 or ≥30 kg/m\^2.
- Present intolerances or allergies related to Agar-Agar, or any of the components of the products being evaluated, such as collagen or maltodextrin.
- Take or have taken medications that may affect the study results. This is especially true for those who have been treated with oral or intra-articular corticosteroids within the 4 and 12 weeks prior to screening...
- Patients who depend on prescription medications for pain control.
- Take multivitamin or mineral supplements, collagen derivatives, or supplements containing bioactive compounds that may exert an anti-inflammatory effect, such as turmeric, ginger, omega-3, or polyphenol supplements...
- Be an active smoker or have been one for less than 6 months.
- Alcohol consumption:
- Men: Consume 4 or more Standard Drink Units (SDU) daily or SDUs weekly.
- Women: Consume 2 or more Standard Drink Units (SDU)\ daily or SDUs weekly.
- Have a diagnosis of osteoarthritis, active rheumatoid arthritis, and any inflammatory arthritic condition such as secondary inflammatory arthritis, gout, pseudogout, knee infection, marked angular deformities, or...
- Have any gastrointestinal disease that affects the absorption of the compound and/or the study results, such as celiac disease, Crohn's disease, active cancer of any organ of the digestive or renal system, or hepatitis.
- Be ineligible to participate in the study, according to the pre-screening evaluator's criteria.
- Have lost 3 kg or more in the last 3 months.
- Be pregnant or intend to become pregnant.
- Be breastfeeding.
- Be unable to follow the study guidelines.
- Be participating or have participated in a clinical trial involving drug intervention or nutritional intervention within the last 30 days prior to inclusion in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Reus, Tarragona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Reus, Tarragona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.