NCT06054633 L-arginine for Knee Osteoarthritis Patients
| NCT ID | NCT06054633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiangya Hospital of Central South University |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2024-03-20 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 340 participants in total. It began in 2024-03-20 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will examine the pain-relief efficacy and safety of L-arginine in knee OA patients.
Eligibility Criteria
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.
Contact & Investigator
Guanghua Lei, MD, PhD
PRINCIPAL INVESTIGATOR
Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT06054633 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06054633 currently recruiting?
Yes, NCT06054633 is actively recruiting participants. Contact the research team at yilun_wang@csu.edu.cn for enrollment information.
Where is the NCT06054633 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06054633 clinical trial?
NCT06054633 is sponsored by Xiangya Hospital of Central South University. The principal investigator is Guanghua Lei, MD, PhD at Xiangya Hospital of Central South University. The trial plans to enroll 340 participants.