Comparison of bovine and marine chondroitin sulfate tablets (800 mg) in treating knee osteoarthritis pain and functional impairment

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What is this study about?

This study focuses on patients with knee osteoarthritis, a condition that causes pain and difficulty with movement in the knee joint. The research compares two different types of chondroitin sulfate tablets – one derived from bovine sources and another from marine sources. Both forms of the medication are given as 800 mg tablets taken orally.

The purpose of this research is to determine if the bovine-derived chondroitin sulfate works as effectively as the marine-derived version for treating pain and reduced function caused by knee osteoarthritis. The study examines how well both medications work in reducing knee pain and improving the ability to perform daily activities.

Participants in this study will take the assigned medication for 24 weeks (6 months). During this time, they will need to record their pain levels and ability to perform everyday activities. After the treatment period ends, there will be a 12-week follow-up period to continue monitoring the effects of the medication. Throughout the study, participants may be allowed to take paracetamol as a pain reliever if needed.

1 Initial treatment period start

You will receive chondroitin sulfate tablets (800 mg) to take daily for 24 weeks (6 months)

The tablets should be taken by mouth (oral route)

You will be randomly assigned to receive either marine or bovine source chondroitin sulfate

2 Week 4 assessment

Your knee pain will be evaluated using a pain scale from 0 to 10

Your ability to perform daily activities will be assessed using a special questionnaire

Your overall quality of life will be evaluated

Both you and your doctor will provide an assessment of your progress

3 Week 12 assessment

Similar evaluations to Week 4 will be performed

Your use of pain relief medication (paracetamol) will be reviewed

Your knee function and pain levels will be reassessed

4 Week 24 (final treatment assessment)

Final evaluation of your knee pain and function

Complete assessment of your quality of life

Review of all medications taken during the study

Final progress evaluation by you and your doctor

5 Follow-up period

Additional 12 weeks of monitoring after treatment ends

Final assessment of knee pain will be conducted

Review of any lasting effects from the treatment

Who Can Join the Study?

  • Must provide written informed consent to participate in the study and agree to personal data processing
  • Must be an outpatient aged 50 years or older, can be male or female
  • Must have knee osteoarthritis diagnosed according to specific medical criteria
  • Must have experienced knee osteoarthritis symptoms (regular pain and limited function) in one or both knees for more than 6 months
  • Must have X-ray evidence of knee osteoarthritis taken within the last 6 months showing moderate severity (if no recent X-ray is available, one will be taken during screening)
  • Must have consistent knee pain scoring between 5 and 9 on a scale of 0-10 (where 0 is no pain and 10 is worst pain) when averaged over 7 days before starting the study
  • Must have limited knee function scoring between 3 and 9 on a scale of 0-10 on a specific arthritis assessment tool
  • Must be able to understand study requirements and be comfortable using electronic devices
  • For women who can become pregnant:
    • Must not be pregnant or breastfeeding
    • Must have a negative pregnancy test at screening
    • Must use effective birth control throughout the study (such as hormonal contraceptives, intrauterine device, or barrier methods)

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • History of allergic reactions to chondroitin sulfate (a natural compound found in cartilage)
  • Previous knee surgery within the last 6 months
  • Current participation in other clinical trials
  • Severe kidney or liver disease
  • Inflammatory joint diseases other than osteoarthritis
  • Pregnancy or breastfeeding
  • Uncontrolled high blood pressure
  • Recent injury to the knee joint (within last 3 months)
  • Use of corticosteroid injections in the knee within the last 3 months
  • Severe mental health conditions that could affect participation
  • Blood clotting disorders or current use of blood thinners
  • Active cancer or cancer treatment
  • Severe obesity that significantly impacts knee function
  • Inability to follow study procedures or attend scheduled visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
EUC Klinika Praha a.s. Prague Czechia
Medical Plus s.r.o. Uherske Hradiste Czechia
Zespol Opieki Zdrowotnej W Boleslawcu Boleslawiec Poland
University Of Debrecen Debrecen Hungary
Vital Medical Center Veszprem Hungary
Omsujnoob Mtgen Dgmyq Kdnkesn skrzxh Cheb Czechia
Ezsyjrtoc a Lznjoywg Ctajpym smuniz Tabor Czechia
Ozgounhwhl Bvg Budapest Hungary
Lcpffyp Bij Kecskemet Hungary
Slzkujwwdsll Krpv Makó Hungary
Rrfibskdx Cuzijv Sqc z oadd Poznan Poland
Cnoprvy Dpbrbwhewfj Mesbbtkid Myrcslrkj Scvz Warsaw Poland
Momrfwu Sww z oiyf Lodz Poland
Cdrkxkr Mtyqnsef Muwygbl Mtnrn Bltnxyuzqek Chrzanow Poland
Mfncj Hrlbnc sxjqgx Klatovy Czechia
Ahpaqojcr seumev Trebovice Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
09.12.2024
Hungary Hungary
Recruiting
09.12.2024
Poland Poland
Recruiting
09.12.2024

Trial locations

Investigated drugs:

Bovine Chondroitin Sulfate
This is a supplement derived from cow cartilage that helps reduce joint pain and improve function in people with knee osteoarthritis. It works by helping to maintain the structure and function of cartilage in the knee joint.

Marine Chondroitin Sulfate
This is a supplement extracted from marine sources (like fish cartilage) that also helps reduce joint pain and improve movement in people with knee osteoarthritis. Like its bovine counterpart, it supports cartilage health and joint function.

Placebo
A placebo tablet that contains no active ingredients is used as a control in this study to compare the effectiveness of both types of chondroitin sulfate.

Investigated diseases:

Knee Osteoarthritis – A degenerative joint disease that affects the knee, characterized by the breakdown of cartilage that cushions the ends of bones. The condition develops gradually as the protective cartilage wears down over time, leading to changes in the underlying bone. It causes joint stiffness, especially in the morning or after periods of inactivity, and typically results in pain that worsens with activity. The affected knee may become swollen, develop bone spurs, and lose its normal range of motion. People with knee osteoarthritis often experience difficulty with daily activities such as walking, climbing stairs, or getting up from a seated position.

Trial ID:
2024-516337-12-00
Protocol code:
23EU-Ct11
Trial Phase:
Therapeutic confirmatory (Phase III)

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