Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05437601 |
| Other study ID # |
BSMMU/2022/5680 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
July 31, 2022 |
| Est. completion date |
December 19, 2022 |
Study information
| Verified date |
April 2024 |
| Source |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
