Osteoarthritis, KneePhase 2/3NCT05138549
Astaxanthin for Management of Inflammation in Knee Osteoarthritis
A Phase 2/3 study testing Astaxanthin in people with Osteoarthritis, Knee and Osteoarthritis Knees Both, run by Prisma Health-Midlands at 1 site in United States.
Trial summary
Over 30 million Americans are currently affected by osteoarthritis (OA), with prevalence expected to increase 40% by 2025 as a result of the aging population and obesity epidemic. Specifically, symptomatic knee OA is a leading cause of disability. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis Knees Both, Joint Inflammation
- What is being tested?
- Astaxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2022to 14 Nov 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Radiographic evidence of advanced knee osteoarthritis
- Knee pain
- Scheduled to undergo a total knee replacement
Who cannot join
- < 18 years of age
- Unable to provide written consent
- Known allergy to fish or astaxanthin
- Pregnant and/or breastfeeding
- Received a corticosteroid injection within 3 months of initiating treatment with astaxanthin or placebo
- Currently taking immunosuppressants
- Patients with known autoimmune etiology for arthritis (e.g. Rheumatoid or Psoriatic arthritis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Astaxanthin for Pain, Function, and Inflammation in Patients With Advanced Osteoarthritis Awaiting Total Knee Replacement Surgery
Over 30 million Americans are currently affected by osteoarthritis (OA), with prevalence expected to increase 40% by 2025 as a result of the aging population and obesity epidemic. Specifically, symptomatic knee OA is a leading cause of disability. Although originally classified as non-inflammatory arthritis, recent studies suggest that a relationship exists between joint inflammation and OA. Specifically, the complex interaction between sites of local tissue damage and immune cells leads to a state of chronic joint inflammation which may play a key role in disease pathogenesis. The evidence suggesting a role of inflammation in disease progression makes anti-inflammatory agents ideal candidates for symptom management. Astaxanthin, a keto-carotenoid present in many aquatic animals, including salmon, shrimp, and lobster, is an FDA-approved nutraceutical that has powerful antioxidant and anti-inflammatory properties coupled with remarkable safety and tolerability. This prospective, blinded, randomized, placebo-controlled pilot study will evaluate the effect of astaxanthin in reducing inflammation, controlling pain, and improving physical function in patients with advanced knee osteoarthritis awaiting total joint replacement surgery. Levels of pro- and anti-inflammatory cytokines and chemokines will be measured following the completion of a daily oral regimen of astaxanthin vs. placebo. Additionally, patient-reported outcome measurements assessing physical function and pain interference will be obtained prior to and following completion of treatment allowing for a comparison between treatment groups. Study outcomes will provide evidence to support astaxanthin supplementation as a cost-effective, added strategy for symptom management in patients with advanced osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is a common degenerative joint disorder that affects a significant portion of the population. Over 30 million Americans are currently affected by the disease, with prevalence expected to increase 40% by 2025 as a result of the aging population and obesity epidemic. Specifically, symptomatic knee OA is a leading cause of disability, occurring in 10% of men and 13% of women over the age of 60. Patients with symptomatic OA often experience pain, swelling, and stiffness of the knee resulting in a decrease in physical mobility which can have a drastic impact on quality of life. In addition to the significant impact on affected individuals, OA is associated with an enormous economic burden estimated at $136.8 billion annually in the US, surpassing costs of tobacco-related health effects, diabetes, and cancer.
Although originally classified as non-inflammatory arthritis, recent studies suggest that a relationship exists between joint inflammation and OA. Specifically, the complex interaction between sites of local tissue damage and immune cells leads to a state of chronic joint inflammation which may play a key role in disease pathogenesis. The evidence suggesting a role of inflammation in disease progression makes anti-inflammatory agents ideal candidates for symptom management. Astaxanthin is a keto-carotenoid present in many aquatic animals, including salmon, shrimp, and lobster, that has demonstrated heightened antioxidant activity and the ability to suppress inflammation. Early evidence suggests that astaxanthin may protect against osteoarthritis in vivo, illustrating its potential as a therapeutic supplement for patients with OA. However, studies illustrating these effects in humans have yet to be conducted.
This prospective, blinded, randomized, placebo-controlled pilot study will evaluate the effect of astaxanthin in reducing inflammation, controlling pain, and improving physical function in patients with advanced knee osteoarthritis awaiting total joint replacement surgery. Levels of pro- and anti-inflammatory cytokines and chemokines will be measured following the completion of a daily oral regimen of astaxanthin vs. placebo. Additionally, patient-reported outcome measurements assessing physical function and pain interference will be obtained prior to and following completion of treatment allowing for a comparison between treatment groups. Study outcomes will provide evidence to support astaxanthin supplementation as a cost-effective, added strategy for symptom management in patients with advanced osteoarthritis.
- Being tested
- Astaxanthin, Placebo
- Medical subject headings
- Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstaxanthinDrug
Also called Astaxanthine, Astaxantina, Dihydroxy-3,3' dioxo-4,4' bêta-carotène
12 mg oral astaxanthin supplement
PlaceboOther
Oral placebo identical to astaxanthin supplement
| Study group | Role | What they receive |
|---|---|---|
| Control: Placebo Group | Placebo comparator | Patients will receive a 6 week daily oral supply of placebo, identical in appearance to the astaxanthin supplement. Receives: Other: Placebo |
| Experimental: Astaxanthin Supplementation Group | Active comparator | Patients will receive a 6 week daily oral supply of 12 mg astaxanthin supplement. Receives: Drug: Astaxanthin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Astaxanthin on Inflammatory Synovial Markers in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery.
We will address this by conducting a prospective, double-blinded, randomized, placebo-controlled trial in which 160 patients who have been diagnosed with advanced osteoarthritis of the knee and are scheduled to undergo a total knee replacement will randomly receive a 6-week oral daily course of either astaxanthin (12 mg) or placebo prior to surgery. Levels of pro- and anti-inflammatory cytokines and chemokines within the intra-articular synovial fluid at the time of surgery will be quantified using a bioplex 23-cytokine and chemokine assay kit in post-treatment synovial fluid samples from patients receiving either astaxanthin or placebo.
Measured: 6 Weeks
Secondary outcomes (2)
Effect of Astaxanthin on PROMIS Physical Function Scores in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery.
Patient reported outcomes will be collected utilizing the Patient Reported Outcome Measurement Information Systems (PROMIS) Physical Function assessment tool. Patients receiving either astaxanthin or placebo will complete PROMIS Physical Function assessment prior to starting the oral treatment regimen and just prior to surgery, following the completion of the oral treatment regimen. As the PROMIS tool has national normative data for age, sex, and condition, collection of patient-reported outcomes in this manner will allow for comparison between patients receiving astaxanthin and patients receiving the placebo as well as the general population. An increased PROMIS Physical Function score indicates an improvement in patient-reported physical function. The scale range is 0 to 100 with a mean of 50 and a standard deviation of 10. Higher values are associated with more or higher function. A score of 60 is one SD better than average. A score of 40 is one SD worse than average.
Measured: 6 Weeks
Effect of Astaxanthin on PROMIS Pain Interference Scores in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery.
Patient reported outcomes will be collected utilizing the Patient Reported Outcome Measurement Information Systems (PROMIS) Pain Interference assessment tool. Patients receiving either astaxanthin or placebo will complete the PROMIS Pain Interference assessment prior to starting the oral treatment regimen and just prior to surgery, following the completion of the oral treatment regimen. As the PROMIS tool has national normative data for age, sex, and condition, collection of patient-reported outcomes in this manner will allow for comparison between patients receiving astaxanthin and patients receiving the placebo as well as the general population. A decreased PROMIS Pain Interference score indicates an improvement in patient-reported pain interference. The scale range is 0 to 100 with a mean of 50 and a standard deviation of 10. Higher values are associated with more or higher pain. A score of 60 is one SD worse pain than average. A score of 40 is one SD better pain than average.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start2 Sep 2022
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Why it stopped: There are not enough eligible patients at our institution to complete this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive 6 weeks of oral supplementation of either placebo or 12 mg astaxanthin prior to total knee replacement surgery.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Midlands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Del Gaizo, MD, Principal investigator, Prisma Health-Midlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138549
- Sponsor's protocol ID
- Pro00113612
- Status last verified
- Mar 2025
- First submitted
- 28 Oct 2021
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
PubMed 20699159Sun K, Luo J, Jing X, Guo J, Yao X, Hao X, Ye Y, Liang S, Lin J, Wang G, Guo F. Astaxanthin protects against osteoarthritis via Nrf2: a guardian of cartilage homeostasis. Aging (Albany NY). 2019 Nov 26;11(22):10513-10531. doi: 10.18632/aging.102474. Epub 2019 Nov 26.
PubMed 31772142Farr Ii J, Miller LE, Block JE. Quality of life in patients with knee osteoarthritis: a commentary on nonsurgical and surgical treatments. Open Orthop J. 2013 Nov 13;7:619-23. doi: 10.2174/1874325001307010619. eCollection 2013.
PubMed 24285987Vitaloni M, Botto-van Bemden A, Sciortino Contreras RM, Scotton D, Bibas M, Quintero M, Monfort J, Carne X, de Abajo F, Oswald E, Cabot MR, Matucci M, du Souich P, Moller I, Eakin G, Verges J. Global management of patients with knee osteoarthritis begins with quality of life assessment: a systematic review. BMC Musculoskelet Disord. 2019 Oct 27;20(1):493. doi: 10.1186/s12891-019-2895-3.
PubMed 31656197Sokolove J, Lepus CM. Role of inflammation in the pathogenesis of osteoarthritis: latest findings and interpretations. Ther Adv Musculoskelet Dis. 2013 Apr;5(2):77-94. doi: 10.1177/1759720X12467868.
PubMed 23641259Scanzello CR, Goldring SR. The role of synovitis in osteoarthritis pathogenesis. Bone. 2012 Aug;51(2):249-57. doi: 10.1016/j.bone.2012.02.012. Epub 2012 Feb 22.
PubMed 22387238Higuera-Ciapara I, Felix-Valenzuela L, Goycoolea FM. Astaxanthin: a review of its chemistry and applications. Crit Rev Food Sci Nutr. 2006;46(2):185-96. doi: 10.1080/10408690590957188.
PubMed 16431409Park JS, Chyun JH, Kim YK, Line LL, Chew BP. Astaxanthin decreased oxidative stress and inflammation and enhanced immune response in humans. Nutr Metab (Lond). 2010 Mar 5;7:18. doi: 10.1186/1743-7075-7-18.
PubMed 20205737
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Astaxanthin for Pain, Function, and Inflammation in Patients With Advanced Osteoarthritis Awaiting Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT05138549
- Acronym / sponsor ID
- Pro00113612
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There are not enough eligible patients at our institution to complete this study.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Prisma Health-MidlandsUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 30 million Americans are currently affected by osteoarthritis (OA), with prevalence expected to increase 40% by 2025 as a result of the aging population and obesity epidemic. Specifically, symptomatic knee OA is a leading cause of disability. Although originally classified as non-inflammatory arthritis, recent studies suggest that a relationship exists between joint inflammation and OA. Specifically, the complex interaction between sites of local tissue damage and immune cells leads to a state of chronic joint inflammation which may play a key role in disease pathogenesis. The evidence suggesting a role of inflammation in disease progression makes anti-inflammatory agents ideal candidates for symptom management. Astaxanthin, a keto-carotenoid present in many aquatic animals, including salmon, shrimp, and lobster, is an FDA-approved nutraceutical that has powerful antioxidant and anti-inflammatory properties coupled with remarkable safety and tolerability. This prospective, blinded, randomized, placebo-controlled pilot study will evaluate the effect of astaxanthin in reducing inflammation, controlling pain, and improving physical function in patients with advanced knee osteoarthritis awaiting total joint replacement surgery. Levels of pro- and anti-inflammatory cytokines and chemokines will be measured following the completion of a daily oral regimen of astaxanthin vs. placebo. Additionally, patient-reported outcome measurements assessing physical function and pain interference will be obtained prior to and following completion of treatment allowing for a comparison between treatment groups. Study outcomes will provide evidence to support astaxanthin supplementation as a cost-effective, added strategy for symptom management in patients with advanced osteoarthritis.
Detailed description
Osteoarthritis (OA) is a common degenerative joint disorder that affects a significant portion of the population. Over 30 million Americans are currently affected by the disease, with prevalence expected to increase 40% by 2025 as a result of the aging population and obesity epidemic. Specifically, symptomatic knee OA is a leading cause of disability, occurring in 10% of men and 13% of women over the age of 60. Patients with symptomatic OA often experience pain, swelling, and stiffness of the knee resulting in a decrease in physical mobility which can have a drastic impact on quality of life. In addition to the significant impact on affected individuals, OA is associated with an enormous economic burden estimated at $136.8 billion annually in the US, surpassing costs of tobacco-related health effects, diabetes, and cancer.
Although originally classified as non-inflammatory arthritis, recent studies suggest that a relationship exists between joint inflammation and OA. Specifically, the complex interaction between sites of local tissue damage and immune cells leads to a state of chronic joint inflammation which may play a key role in disease pathogenesis. The evidence suggesting a role of inflammation in disease progression makes anti-inflammatory agents ideal candidates for symptom management. Astaxanthin is a keto-carotenoid present in many aquatic animals, including salmon, shrimp, and lobster, that has demonstrated heightened antioxidant activity and the ability to suppress inflammation. Early evidence suggests that astaxanthin may protect against osteoarthritis in vivo, illustrating its potential as a therapeutic supplement for patients with OA. However, studies illustrating these effects in humans have yet to be conducted.
This prospective, blinded, randomized, placebo-controlled pilot study will evaluate the effect of astaxanthin in reducing inflammation, controlling pain, and improving physical function in patients with advanced knee osteoarthritis awaiting total joint replacement surgery. Levels of pro- and anti-inflammatory cytokines and chemokines will be measured following the completion of a daily oral regimen of astaxanthin vs. placebo. Additionally, patient-reported outcome measurements assessing physical function and pain interference will be obtained prior to and following completion of treatment allowing for a comparison between treatment groups. Study outcomes will provide evidence to support astaxanthin supplementation as a cost-effective, added strategy for symptom management in patients with advanced osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive 6 weeks of oral supplementation of either placebo or 12 mg astaxanthin prior to total knee replacement surgery.
| Arm | Type | Receives |
|---|---|---|
| Control: Placebo Group | Placebo comparator | Other: PlaceboPatients will receive a 6 week daily oral supply of placebo, identical in appearance to the astaxanthin supplement. |
| Experimental: Astaxanthin Supplementation Group | Active comparator | Drug: AstaxanthinPatients will receive a 6 week daily oral supply of 12 mg astaxanthin supplement. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- Radiographic evidence of advanced knee osteoarthritis
- Knee pain
- Scheduled to undergo a total knee replacement
Key exclusion criteria (7 listed)
- < 18 years of age
- Unable to provide written consent
- Known allergy to fish or astaxanthin
- Pregnant and/or breastfeeding
- Received a corticosteroid injection within 3 months of initiating treatment with astaxanthin or placebo
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 |
|---|---|---|
| AstaxanthinAlso: Astaxanthine, Astaxantina, Dihydroxy-3,3' dioxo-4,4' bêta-carotène12 mg oral astaxanthin supplement | Drug | Experimental: Astaxanthin Supplementation Group |
| PlaceboOral placebo identical to astaxanthin supplement | Other | Control: Placebo Group |
Primary outcome
Effect of Astaxanthin on Inflammatory Synovial Markers in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery.
Time frame: 6 Weeks
We will address this by conducting a prospective, double-blinded, randomized, placebo-controlled trial in which 160 patients who have been diagnosed with advanced osteoarthritis of the knee and are scheduled to undergo a total knee replacement will randomly receive a 6-week oral daily course of either astaxanthin (12 mg) or placebo prior to surgery. Levels of pro- and anti-inflammatory cytokines and chemokines within the intra-articular synovial fluid at the time of surgery will be quantified using a bioplex 23-cytokine and chemokine assay kit in post-treatment synovial fluid samples from patients receiving either astaxanthin or placebo.
2 secondary outcomes
Effect of Astaxanthin on PROMIS Physical Function Scores in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery.
Time frame: 6 Weeks
Effect of Astaxanthin on PROMIS Pain Interference Scores in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20699159Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
- Background: PubMed 31772142Sun K, Luo J, Jing X, Guo J, Yao X, Hao X, Ye Y, Liang S, Lin J, Wang G, Guo F. Astaxanthin protects against osteoarthritis via Nrf2: a guardian of cartilage homeostasis. Aging (Albany NY). 2019 Nov 26;11(22):10513-10531. doi: 10.18632/aging.102474. Epub 2019 Nov 26.
- Background: PubMed 24285987Farr Ii J, Miller LE, Block JE. Quality of life in patients with knee osteoarthritis: a commentary on nonsurgical and surgical treatments. Open Orthop J. 2013 Nov 13;7:619-23. doi: 10.2174/1874325001307010619. eCollection 2013.
- Background: PubMed 31656197Vitaloni M, Botto-van Bemden A, Sciortino Contreras RM, Scotton D, Bibas M, Quintero M, Monfort J, Carne X, de Abajo F, Oswald E, Cabot MR, Matucci M, du Souich P, Moller I, Eakin G, Verges J. Global management of patients with knee osteoarthritis begins with quality of life assessment: a systematic review. BMC Musculoskelet Disord. 2019 Oct 27;20(1):493. doi: 10.1186/s12891-019-2895-3.
- Background: PubMed 23641259Sokolove J, Lepus CM. Role of inflammation in the pathogenesis of osteoarthritis: latest findings and interpretations. Ther Adv Musculoskelet Dis. 2013 Apr;5(2):77-94. doi: 10.1177/1759720X12467868.
- Background: PubMed 22387238Scanzello CR, Goldring SR. The role of synovitis in osteoarthritis pathogenesis. Bone. 2012 Aug;51(2):249-57. doi: 10.1016/j.bone.2012.02.012. Epub 2012 Feb 22.
- Background: PubMed 16431409Higuera-Ciapara I, Felix-Valenzuela L, Goycoolea FM. Astaxanthin: a review of its chemistry and applications. Crit Rev Food Sci Nutr. 2006;46(2):185-96. doi: 10.1080/10408690590957188.
- Background: PubMed 20205737Park JS, Chyun JH, Kim YK, Line LL, Chew BP. Astaxanthin decreased oxidative stress and inflammation and enhanced immune response in humans. Nutr Metab (Lond). 2010 Mar 5;7:18. doi: 10.1186/1743-7075-7-18.
- 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.
Daniel Del Gaizo, MD principal investigator
Prisma Health-Midlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Astaxanthin in people with Osteoarthritis, Knee and Osteoarthritis Knees Both, run by Prisma Health-Midlands at 1 site in United States.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Astaxanthin on Inflammatory Synovial Markers in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery. (time frame: 6 Weeks). 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 NCT05138549, which also lists 8 linked publications.
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 20 May 2025.