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Effect of Astaxanthin in Moderate to Severe Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Astaxanthin Oral Capsule
Placebo
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with knee pain
  • Radiographic evidence of moderate to severe knee osteoarthritis
  • Age 40 years or older
  • Both male and female

Exclusion Criteria:

  • 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

Sites / Locations

  • Bangabandhu Sheikh Mujib Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Astaxanthin

Control

Arm Description

Patients will receive three capsules of astaxanthin (4mg) daily for 8 weeks.

Patients will receive three capsules of placebo daily for 8 weeks.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Serum IL-6
will be measured by commercially available ELISA kits before and after intervention
High sensitive C-reactive protein
will be measured before and after intervention

Full Information

First Posted
June 27, 2022
Last Updated
June 29, 2022
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT05437601
Brief Title
Effect of Astaxanthin in Moderate to Severe Knee Osteoarthritis
Official Title
Effect of Astaxanthin in Reducing Disease Activity in Moderate to Severe Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to receive either 12 mg astaxanthin capsules or placebo capsules for 8 weeks
Masking
ParticipantInvestigator
Masking Description
Participants and investigators will not know which arm patients have been assigned to or if they receive placebo or astaxanthin
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Astaxanthin
Arm Type
Experimental
Arm Description
Patients will receive three capsules of astaxanthin (4mg) daily for 8 weeks.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients will receive three capsules of placebo daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Astaxanthin Oral Capsule
Other Intervention Name(s)
3,3'-dihydroxy-4,4'-diketo-β-β carotene,
Intervention Description
12 mg oral astaxanthin daily for 8 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral placebo identical to astaxanthin
Primary Outcome Measure Information:
Title
Effect of astaxanthin on Improvement of pain, stiffness and physical function
Description
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)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Serum IL-6
Description
will be measured by commercially available ELISA kits before and after intervention
Time Frame
8 weeks
Title
High sensitive C-reactive protein
Description
will be measured before and after intervention
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with knee pain Radiographic evidence of moderate to severe knee osteoarthritis Age 40 years or older Both male and female Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masuma Tabassum, MBBS
Phone
+8801714492952
Email
masumatabassum09@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Md. Sayedur Rahman, FCPS, Mphil
Phone
+8801712205305
Email
srkhasru@bsmmu.edu.bd
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masuma Tabassum, MBBS
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Registrar
Phone
+889661064
Email
registrar@bsmmu.edu.bd

12. IPD Sharing Statement

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Effect of Astaxanthin in Moderate to Severe Knee Osteoarthritis

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