Clinical trial NCT06960694: Effect of L-carnitine on Disease Activity in Patients With Mild to Moderate Knee Osteoarthritis
Official title: Effect of L-carnitine on Disease Activity in Patients With Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
L-carnitine
knee osteoarthritis
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 a total of 72 patients with knee OA. The participants will be randomly be assigned into two groups: Intervention group and Placebo group. Patients of Intervention group will receive tablet Naproxen 500 mg two times per day as conventional treatment for 14 days and tablet L-carnitine 330 mg 3 times daily for 8 weeks. The patients of Placebo group will receive tablet Naproxen 500 mg two times per day as conventional treatment for 14 days and tablet placebo 330 mg 3 times daily for the 8 weeks. Data will be analyzed by Statistical Package for the Social Sciences (SPSS). The significant p-value is \<0.05. 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.

Eligibility criteria: Inclusion Criteria:

* Knee pain
* Radiographic evidence of mild to moderate knee osteoarthritis (Kellgren-Lawrence Grade: II-III)
* Above 40 years
* Both male and female
* hs-CRP ≥ 0.3mg/dl

Exclusion Criteria:

* Renal impairment (S. creatinine \>1.5 mg/dl)
* 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 three 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 naproxen in last 2 months
* Pregnancy or lactation
* Participation in another clinical trial

Primary outcomes:
measure: Pain, stiffness and physical function
timeFrame: 8 weeks
Secondary outcomes:
measure: Oxidative stress markers (Malondialdehyde and Glutathione)
timeFrame: 8 weeks
measure: Inflammatory marker (hs-CRP)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Moumita Ghosh, MBBS
role: PRINCIPAL_INVESTIGATOR
References: