Osteoarthritis, KneePhase 2NCT05437601
Effect of Astaxanthin in Moderate to Severe Knee Osteoarthritis
A Phase 2 study testing Astaxanthin Oral Capsule in people with Osteoarthritis, Knee, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
This study will be 8 weeks randomized, double-blind, placebo-controlled trail to assess the effect of astaxanthin in 80 moderate to severe knee osteoarthritis patients. Participants will be assessed at baseline and after 8 weeks of intervention. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Astaxanthin Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBangladesh
- Study dates
- 31 Jul 2022to 19 Dec 2022
- Phase
- Phase 2
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with knee pain
- Radiographic evidence of moderate to severe knee osteoarthritis
- Age 40 years or older
- Both male and female
Who cannot join
- Prior history of knee trauma or surgery
- Previously diagnosed of systemic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease
- Known allergy to fish or astaxanthin
- Currently taking immunosuppressant
- Pregnant and nursing mother
- Patients unwilling to participate or unwilling to give written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Astaxanthin in Reducing Disease Activity in Moderate to Severe Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial
This study will be 8 weeks randomized, double-blind, placebo-controlled trail to assess the effect of astaxanthin in 80 moderate to severe knee osteoarthritis patients. Participants will be assessed at baseline and after 8 weeks of intervention. Subjects will be randomized to receive either astaxanthin 12 mg capsule daily or placebo capsule identical to astaxanthin daily for 8 weeks. Evaluation of pain, stiffness and improvement of physical function will be measured by WOMAC index before and after intervention. Inflammatory markers serum IL-6 and hsCRP will be measured before and after intervention. Astaxanthin related adverse events will be identified. Study outcome will establish safety and efficacy of astaxanthin in knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is the leading cause of disability worldwide and knee is the commonest joint involved. In 2020 there were around 654.1 million individuals (40 years and older) with knee OA and this prevalence tend to increase rapidly due to the growing aging of the population as well as an increase in risk factors particularly obesity and sedentary lifestyle. Evidences show that OA is associated with chronic low grade inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the mainstay of management for OA symptoms which however cause serious gastrointestinal, renal and cardiovascular adverse events. With the lack of safe and effective therapies for OA, many patients are eventually faced with costly total joint replacement as the only option to improve pain, function, and quality of life. Astaxanthin is a natural oxycarotenoid which exhibits strong anti-inflammatory and anti-oxidant effects and is a promising therapeutic potential in OA. Till date sufficient data is not available regarding effects of astaxanthin in OA in human. This study is an effort to explore whether astaxanthin as add on therapy with conventional treatment of OA produce improvement in disease activity and inflammatory indicators in moderate to severe knee OA patients. This study will be a randomized, double-blind, placebo-controlled trial and will be conducted in the Department of Pharmacology, BSMMU in collaboration with the Department of Physical Medicine and Rehabilitations, BSMMU. A total of eighty (80) OA patients attended in the outpatient Department of Physical Medicine and Rehabilitations, BSMMU will be selected for the study according to inclusion and exclusion criteria. Diagnosis of moderate and severe knee OA will be made radiologically by an expert physiatrist of Department of Physical Medicine and Rehabilitations, BSMMU using the Kellgren-Lawrence grading scale. Each participant will be assessed by translated and validated Bangla version of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) VA3.01 in a calm place in the BSMMU campus for pain, stiffness and physical function. Serum Interleukin-6 (IL-6) and high sensitive C-reactive protein (hsCRP) will be measured. Then participants will randomly be assigned into two groups: Intervention group and Control group. The intervention group patients will receive conventional treatment with astaxanthin 3 capsules of 4mg after breakfast daily for 8 weeks making a total dose of 12 mg astaxanthin/day. On the other hand, patients in control group will receive 3 placebo capsules of 4 mg after breakfast daily for 8 weeks along with conventional treatment given by the physiatrist. The regularity of medicine intake will be ensured over telephone, capsule count and from the patient's compliance sheet. After 8 weeks of therapy each participant will be assessed once again by Bangla version of WOMAC Index and serum IL-6 and hsCRP will be measured. Patients will be asked to inform if they encountered any astaxanthin related adverse events. Study outcomes will provide evidence to support astaxanthin's safety and efficacy as an added strategy for symptom management in patients with knee osteoarthritis.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Astaxanthin Oral Capsule, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astaxanthin Oral CapsuleDrug
Also called 3,3'-dihydroxy-4,4'-diketo-β-β carotene,
12 mg oral astaxanthin daily for 8 weeks
PlaceboOther
Oral placebo identical to astaxanthin
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin | Experimental | Patients will receive three capsules of astaxanthin (4mg) daily for 8 weeks. Receives: Drug: Astaxanthin Oral Capsule |
| Control | Placebo comparator | Patients will receive three capsules of placebo daily for 8 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of astaxanthin on Improvement of pain, stiffness and physical function
The investigators will address this by conducting a prospective, double-blinded, randomized, placebo-controlled trial in which 80 patients who have been diagnosed with moderate to severe osteoarthritis of the knee will randomly receive a 8-week oral daily course of either astaxanthin (12 mg) or placebo. Improvement of pain, stiffness and physical function will be measured by translated and validated Bangla version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: 8 weeks
Secondary outcomes (2)
Serum IL-6
will be measured by commercially available ELISA kits before and after intervention
Measured: 8 weeks
High sensitive C-reactive protein
will be measured before and after intervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start31 Jul 2022
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive either 12 mg astaxanthin capsules or placebo capsules for 8 weeks
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masuma Tabassum, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Masuma Tabassum, MBBS, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437601
- Sponsor's protocol ID
- BSMMU/2022/5680
- Status last verified
- Apr 2024
- First submitted
- 27 Jun 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Astaxanthin in Reducing Disease Activity in Moderate to Severe Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05437601
- Acronym / sponsor ID
- BSMMU/2022/5680
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 31 Jul 2022 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 29 Jun 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.
This study will be 8 weeks randomized, double-blind, placebo-controlled trail to assess the effect of astaxanthin in 80 moderate to severe knee osteoarthritis patients. Participants will be assessed at baseline and after 8 weeks of intervention. Subjects will be randomized to receive either astaxanthin 12 mg capsule daily or placebo capsule identical to astaxanthin daily for 8 weeks. Evaluation of pain, stiffness and improvement of physical function will be measured by WOMAC index before and after intervention. Inflammatory markers serum IL-6 and hsCRP will be measured before and after intervention. Astaxanthin related adverse events will be identified. Study outcome will establish safety and efficacy of astaxanthin in knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is the leading cause of disability worldwide and knee is the commonest joint involved. In 2020 there were around 654.1 million individuals (40 years and older) with knee OA and this prevalence tend to increase rapidly due to the growing aging of the population as well as an increase in risk factors particularly obesity and sedentary lifestyle. Evidences show that OA is associated with chronic low grade inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the mainstay of management for OA symptoms which however cause serious gastrointestinal, renal and cardiovascular adverse events. With the lack of safe and effective therapies for OA, many patients are eventually faced with costly total joint replacement as the only option to improve pain, function, and quality of life. Astaxanthin is a natural oxycarotenoid which exhibits strong anti-inflammatory and anti-oxidant effects and is a promising therapeutic potential in OA. Till date sufficient data is not available regarding effects of astaxanthin in OA in human. This study is an effort to explore whether astaxanthin as add on therapy with conventional treatment of OA produce improvement in disease activity and inflammatory indicators in moderate to severe knee OA patients. This study will be a randomized, double-blind, placebo-controlled trial and will be conducted in the Department of Pharmacology, BSMMU in collaboration with the Department of Physical Medicine and Rehabilitations, BSMMU. A total of eighty (80) OA patients attended in the outpatient Department of Physical Medicine and Rehabilitations, BSMMU will be selected for the study according to inclusion and exclusion criteria. Diagnosis of moderate and severe knee OA will be made radiologically by an expert physiatrist of Department of Physical Medicine and Rehabilitations, BSMMU using the Kellgren-Lawrence grading scale. Each participant will be assessed by translated and validated Bangla version of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) VA3.01 in a calm place in the BSMMU campus for pain, stiffness and physical function. Serum Interleukin-6 (IL-6) and high sensitive C-reactive protein (hsCRP) will be measured. Then participants will randomly be assigned into two groups: Intervention group and Control group. The intervention group patients will receive conventional treatment with astaxanthin 3 capsules of 4mg after breakfast daily for 8 weeks making a total dose of 12 mg astaxanthin/day. On the other hand, patients in control group will receive 3 placebo capsules of 4 mg after breakfast daily for 8 weeks along with conventional treatment given by the physiatrist. The regularity of medicine intake will be ensured over telephone, capsule count and from the patient's compliance sheet. After 8 weeks of therapy each participant will be assessed once again by Bangla version of WOMAC Index and serum IL-6 and hsCRP will be measured. Patients will be asked to inform if they encountered any astaxanthin related adverse events. Study outcomes will provide evidence to support astaxanthin's safety and efficacy as an added strategy for symptom management in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive either 12 mg astaxanthin capsules or placebo capsules for 8 weeks
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin | Experimental | Drug: Astaxanthin Oral CapsulePatients will receive three capsules of astaxanthin (4mg) daily for 8 weeks. |
| Control | Placebo comparator | Other: PlaceboPatients will receive three capsules of placebo daily for 8 weeks. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with knee pain
- Radiographic evidence of moderate to severe knee osteoarthritis
- Age 40 years or older
- Both male and female
Key exclusion criteria (6 listed)
- Prior history of knee trauma or surgery
- Previously diagnosed of systemic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease
- Known allergy to fish or astaxanthin
- Currently taking immunosuppressant
- Pregnant and nursing mother
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 |
|---|---|---|
| Astaxanthin Oral CapsuleAlso: 3,3'-dihydroxy-4,4'-diketo-β-β carotene,12 mg oral astaxanthin daily for 8 weeks | Drug | Astaxanthin |
| PlaceboOral placebo identical to astaxanthin | Other | Control |
Primary outcome
Effect of astaxanthin on Improvement of pain, stiffness and physical function
Time frame: 8 weeks
The investigators will address this by conducting a prospective, double-blinded, randomized, placebo-controlled trial in which 80 patients who have been diagnosed with moderate to severe osteoarthritis of the knee will randomly receive a 8-week oral daily course of either astaxanthin (12 mg) or placebo. Improvement of pain, stiffness and physical function will be measured by translated and validated Bangla version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
2 secondary outcomes
Serum IL-6
Time frame: 8 weeks
High sensitive C-reactive protein
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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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.
Masuma Tabassum, MBBS principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Astaxanthin Oral Capsule in people with Osteoarthritis, Knee, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 6 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: finished, as of the sponsor's last update on 18 Apr 2024. 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 Bangladesh. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Improvement of pain, stiffness and physical function (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2024.