Effect of Astaxanthin in Moderate to Severe Knee Osteoarthritis

NCT05437601 | Completed Phase 2

• 1 other identifier: BSMMU/2022/5680
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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)

  8 weeks

Secondary Outcomes (2)

• Serum IL-6

  8 weeks

• High sensitive C-reactive protein

  8 weeks

Study Arms (2)

Astaxanthin

EXPERIMENTAL

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

Drug: Astaxanthin Oral Capsule

Control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Astaxanthin Oral Capsule DRUG

12 mg oral astaxanthin daily for 8 weeks

Also known as: 3,3'-dihydroxy-4,4'-diketo-β-β carotene,

Astaxanthin

Placebo OTHER

Oral placebo identical to astaxanthin

Control

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Masuma Tabassum, MBBS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will not know which arm patients have been assigned to or if they receive placebo or astaxanthin
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Patients will be randomized to receive either 12 mg astaxanthin capsules or placebo capsules for 8 weeks

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 29, 2022
• Study Start: July 31, 2022
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

BA (1)