Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Dhaka, 1000, Bangladesh
NCT Number: NCT06960694
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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Notify Me40 year and older
All sexes
Interventional
Phase 2
Dhaka, 1000, Bangladesh
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This group will be treated with tablet L-carnitine 330 mg 3 times daily for 8 weeks
Other names: Levocarnitine
This group will be treated with tablet Placebo 330 mg 3 times daily for 8 weeks
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
Time frame: 8 weeks
Time frame: 8 weeks
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Other
Effect of L-carnitine on Disease Activity in Patients With Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial
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