Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 10:48 PM
Study NCT ID:
NCT06960694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-07
First Post:
2025-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of L-carnitine on Disease Activity in Patients With Mild to Moderate Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002331', 'term': 'Carnitine'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2025-04-29', 'studyFirstSubmitQcDate': '2025-04-29', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain, stiffness and physical function', 'timeFrame': '8 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Oxidative stress markers (Malondialdehyde and Glutathione)', 'timeFrame': '8 weeks'}, {'measure': 'Inflammatory marker (hs-CRP)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'L-carnitine', 'knee osteoarthritis'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Knee pain\n* Radiographic evidence of mild to moderate knee osteoarthritis (Kellgren-Lawrence Grade: II-III)\n* Above 40 years\n* Both male and female\n* hs-CRP ≥ 0.3mg/dl\n\nExclusion Criteria:\n\n* Renal impairment (S. creatinine \\>1.5 mg/dl)\n* Diagnosed with systemic inflammatory disorders, such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, gout\n* Patients on immunosuppressant treatment\n* Any history of intra-articular corticosteroid injections during the previous three months\n* A history of knee surgery or trauma\n* Any antioxidant vitamins use, such as A, C and E or history of use in the last two months\n* History of taking L-carnitine and naproxen in last 2 months\n* Pregnancy or lactation\n* Participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT06960694', 'briefTitle': 'Effect of L-carnitine on Disease Activity in Patients With Mild to Moderate Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, 'officialTitle': 'Effect of L-carnitine on Disease Activity in Patients With Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'BMU/2025/5899'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Intervention group)', 'interventionNames': ['Drug: L-carnitine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B (Placebo group)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'L-carnitine', 'type': 'DRUG', 'otherNames': ['Levocarnitine'], 'description': 'This group will be treated with tablet L-carnitine 330 mg 3 times daily for 8 weeks and Naproxen 500 mg twice daily for the first 14 days', 'armGroupLabels': ['Group A (Intervention group)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'This group will be treated with tablet Placebo 330 mg 3 times daily for 8 weeks and Naproxen 500 mg twice daily for the first 14 days', 'armGroupLabels': ['Group B (Placebo group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Dhaka', 'country': 'Bangladesh', 'contacts': [{'name': 'Moumita Ghosh, MBBS', 'role': 'CONTACT', 'email': 'dr.mitamou@gmail.com', 'phone': '+8801780314660'}, {'name': 'Sajib Kumar Talukdhar, MBBS, MD', 'role': 'CONTACT', 'email': 'sajibkumar@bsmmu.edu.bd', 'phone': '+8801723620231'}, {'name': 'Moumita Ghosh, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Moumita Ghosh, MBBS', 'role': 'CONTACT', 'email': 'dr.mitamou@gmail.com', 'phone': '+8801780314660'}, {'name': 'Sajib Kumar Talukdhar, MBBS, MD', 'role': 'CONTACT', 'email': 'sajibkumar@bsmmu.edu.bd', 'phone': '+8801723620231'}], 'overallOfficials': [{'name': 'Moumita Ghosh, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Resident (Phase-B), Department of Pharmacology', 'investigatorFullName': 'Moumita Ghosh', 'investigatorAffiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}}}}