RecruitingNot ApplicableNCT06054633
L-arginine for Knee Osteoarthritis Patients
Efficacy and Safety of Oral L-Arginine for Pain Relief in Knee Osteoarthritis: a Randomized, Double-Blind, Placebo-Controlled Trial
Sponsor
Xiangya Hospital of Central South University
Enrollment
340 participants
Start Date
Mar 20, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This study will examine the pain-relief efficacy and safety of L-arginine in knee OA patients.
Eligibility
Min Age: 40 YearsMax Age: 80 Years
Inclusion Criteria5
- Age between 40 and 80 years.
- Knee OA according to the American College of Rheumatology (ACR) clinical criteria.
- Knee pain lasting 3 months or longer and a score of 7 or greater on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (standardized to range from 0-20).
- Kellgren-Lawrence (KL) grade 2 or 3.
- Willing to and able to provide written informed consent.
Exclusion Criteria12
- Any use of NSAIDs or other analgesics in the past two weeks.
- History of injections of corticosteroids in the past three months or hyaluronic acid in the past 6 months in the index knee.
- History of arthroscopy or open surgery in the index knee in the past 12 months.
- History of a knee replacement in the index knee or planning to receive such a procedure within 3 months.
- History of a severe injury in the index knee.
- Pain in the index knee caused by inflammatory, autoimmune, neoplastic diseases or other diseases.
- Abnormal liver or kidney functions, as defined by alanine transaminase or aspartate aminotransferase >two times the upper limit of normal, or blood urea nitrogen or serum creatinine >two times the upper limit of normal.
- Severe respiratory diseases.
- History of coronary artery disease and heart failure.
- Uncontrolled hypertension or diabetes mellitus.
- Diagnosis of malignant tumors.
- Pregnant or contemplating pregnancy or breast-feeding.
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Interventions
DIETARY_SUPPLEMENTL-arginine tablet
L-arginine, 2 g, three times daily, for 12 weeks
DIETARY_SUPPLEMENTPlacebo tablet
Identical inert placebo, three times daily, for 12 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06054633
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