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

NCT ID: NCT06960694

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-28
• Study Completion Date: 2025-11-19

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 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A (Intervention group)

Group Type: EXPERIMENTAL

L-carnitine

Intervention Type: DRUG

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

Group B (Placebo group)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

L-carnitine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Levocarnitine

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

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Moumita Ghosh

MD Resident (Phase-B), Department of Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moumita Ghosh, MBBS

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

BMU/2025/5899

Identifier Type: -

Identifier Source: org_study_id