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Completed

NCT Number: NCT06960694

Effect of L-carnitine on Disease Activity in Patients With Mild to Moderate Knee Osteoarthritis

The purpose of this study is to evaluate the effects of L-carnitine on symptomatic improvement, oxidative stress, and inflammation in mild to moderate knee osteoarthritis patients.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Dhaka, 1000, Bangladesh

About this study

Osteoarthritis (OA) is a progressive degenerative joint disease marked by cartilage degradation, synovial inflammation, and subchondral bone remodeling, resulting in persistent pain and disability. The most prevalent arthritis is OA, and responsible for most adult chronic pain and permanent disability. Osteoarthritis affected 595 million individuals worldwide in 2020, which accounted for 7.6% of the world's population. The most common kind of OA is knee osteoarthritis. Currently, there is no safe and effective therapy for knee OA. Nonsteroidal anti-inflammatory medicines are commonly used to treat the symptoms of osteoarthritis, but long-term usage can lead to renal and cardiac complications. There is a higher demand for medicine that not only relieve symptoms but also decrease disease progression. Recently, there has been an increase in interest in complementary and alternative therapies, particularly nutritional supplements. L-carnitine, a naturally occurring chemical, is required for carrying long-chain fatty acids to the mitochondria, where they are oxidized to generate energy. It is mostly generated in the liver and kidneys from the amino acids-lysine and methionine. Research has demonstrated that L-carnitine has anti-inflammatory and antioxidant characteristics. Several animal and human studies have indicated that it improves osteoarthritis by lowering oxidative stress and inflammation. The proposed study aims to determine whether L-carnitine is more effective in lowering disease activity in mild to moderate knee OA compared to placebo. It will be a single-center study, utilizing a double-blind, randomized placebo-controlled trial design. The study will involve 66 patients with mild to moderate knee OA. The participants will be randomly be assigned into two groups: Intervention group and Placebo group. Patients of Intervention group will receive tablet L-carnitine 330 mg 3 times daily for 8 weeks. The patients of Placebo group will receive tablet placebo 330 mg 3 times daily for the 8 weeks. In this study, we will evaluate MDA (Malondialdehyde), GSH (Glutathione), and hs-CRP (high-sensitivity C-reactive protein) concentrations and three dimensions (pain, stiffness and physical activity) of Bangla version of WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index). In addition, we will assess various sociodemographic characteristics of all the participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Knee pain
  • Radiographic evidence of mild to moderate knee osteoarthritis (Kellgren-Lawrence Grade: II-III)
  • Above 40 years
  • Both male and female

Exclusion criteria

  • Chronic kidney disease or chronic liver disease
  • Diagnosed with systemic inflammatory disorders, such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, gout
  • Patients on immunosuppressant treatment
  • Any history of intra-articular corticosteroid injections during the previous 2 months
  • A history of knee surgery or trauma
  • Any antioxidant vitamins use, such as A, C, and E, or history of use in the last two months
  • History of taking L-carnitine and NSAIDs in last 2 months
  • Pregnancy or lactation
  • Participation in another clinical trial

Treatment and study plan

L-carnitine

Drug

This group will be treated with tablet L-carnitine 330 mg 3 times daily for 8 weeks

Other names: Levocarnitine

Placebo

Drug

This group will be treated with tablet Placebo 330 mg 3 times daily for 8 weeks

Primary outcomes

  1. Pain, stiffness and physical function

    Time frame: 8 weeks

    To assess and compare pain, stiffness and physical function in mild to moderate knee osteoarthritis patients, a translated and validated Bangla version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) VA3.01 will be used

Secondary outcomes

  1. Oxidative stress markers (Malondialdehyde and Glutathione)

    Time frame: 8 weeks

  2. Inflammatory marker (hs-CRP)

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

Effect of L-carnitine on Disease Activity in Patients With Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 7, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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