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

NCT06960694 | Completed Phase 2 DMC

• 1 other identifier: BMU/2025/5899
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; L-carnitine; knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Pain, stiffness and physical function

  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

  8 weeks

Secondary Outcomes (2)

• Oxidative stress markers (Malondialdehyde and Glutathione)

  8 weeks

• Inflammatory marker (hs-CRP)

  8 weeks

Study Arms (2)

Group A (Intervention group)

EXPERIMENTAL

Drug: L-carnitine

Group B (Placebo group)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

L-carnitine DRUG

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

Also known as: Levocarnitine

Group A (Intervention group)

Placebo DRUG

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

Group B (Placebo group)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Moumita Ghosh, 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Resident (Phase-B), Department of Pharmacology

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: June 28, 2025
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: February 6, 2026

Record last verified: 2025-04

Locations

BA (1)