L-arginine tablet: L-arginine, 2 g, three times daily, for 12 weeks
Placebo tablet: Identical inert placebo, three times daily, for 12 weeks
Study summary
This study will examine the pain-relief efficacy and safety of L-arginine in knee OA patients.
Eligibility
Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age between 40 and 80 years.
2. Knee OA according to the American College of Rheumatology (ACR) clinical criteria.
3. 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).
4. Kellgren-Lawrence (KL) grade 2 or 3.
5. Willing to and able to provide written informed consent.
Exclusion Criteria:
1. Any use of NSAIDs or other analgesics in the past two weeks.
2. History of injections of corticosteroids in the past three months or hyaluronic acid in the past 6 months in the index knee.
3. History of arthroscopy or open surgery in the index knee in the past 12 months.
4. History of a knee replacement in the index knee or planning to receive such a procedure within 3 months.
5. History of a severe injury in the index knee.
6. Pain in the index knee caused by inflammatory, autoimmune, neoplastic diseases or other diseases.
7. 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.
8. Severe respiratory diseases.
9. History of coronary artery disease and heart failure.
10. Uncontrolled hypertension or diabetes mellitus.
11. Diagnosis of malignant tumors.
12. Pregnant or contemplating pregnancy or breast-feeding.
Primary outcome measure(s)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. — Baseline, Week 12 WOMAC is a self-administered, disease-specific questionnaire that assesses the severity of OA symptoms. The reliability and validity of WOMAC have been confirmed in many clinical trials. WOMAC subscales consist of pain (5 items), stiffness (2 items), and physical function (17 items). Each item is rated from 0 to 4, totaling scores of 0-20, 0-8, and 0-68 for pain, stiffness, and function subscales, respectively.
Trial sites (1)
Facility
City
Region
Status
Xiangya Hospital
Changsha
Hunan
Recruiting
More Xiangya Hospital of Central South University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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