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Effect of Astaxanthin in Moderate to Severe Knee Osteoarthritis

NCT05437601 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Astaxanthin Oral Capsule

12 mg oral astaxanthin daily for 8 weeks

OTHER

Placebo

Oral placebo identical to astaxanthin

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Masuma Tabassum, MBBS · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2022-12-19
Completion
2022-12-19

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05437601 on ClinicalTrials.gov