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)

Xiangya Hospital

Changsha, Hunan, China

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NCT06054633


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