Overview
Effect of Astaxanthin in Moderate to Severe Knee Osteoarthritis
Status:
Recruiting
Recruiting
Trial end date:
2023-01-01
2023-01-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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