L-arginine for Knee Osteoarthritis Patients

NCT06054633 | Recruiting DMC

• 1 other identifier: 20230608
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the pain-relief efficacy and safety of L-arginine in knee OA patients.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; L-arginine; Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score.

  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.

  Baseline, Week 12

Secondary Outcomes (14)

• Change From Baseline in WOMAC pain score.

  Baseline, Weeks 2, 4 and 8

• Change From Baseline in Knee pain on a visual analogue scale (VAS).

  Baseline, Weeks 2, 4, 8 and 12

• Change From Baseline in WOMAC total score.

  Baseline, Weeks 2, 4, 8 and 12

• Change From Baseline in Change From Baseline in WOMAC stiffness score.

  Baseline, Weeks 2, 4, 8 and 12

• Change From Baseline in WOMAC function score.

  Baseline, Weeks 2, 4, 8 and 12

Other Outcomes (9)

• Change From Baseline in Short Physical Performance Battery (SPPB) scores.

  Baseline, Weeks 4, 8 and 12

• Change From Baseline in Grip strength.

  Baseline, Weeks 4, 8 and 12

• Change From Baseline in Bone mineral density (BMD).

  Baseline, Week 12

Study Arms (2)

Oral L-arginine

ACTIVE COMPARATOR

Participants in the intervention arm will receive oral L- arginine tablets, 2 g three times daily

Dietary Supplement: L-arginine tablet

Placebo

PLACEBO COMPARATOR

The control group will receive an identical inert placebo tablet, three times daily

Dietary Supplement: Placebo tablet

Interventions

L-arginine tablet DIETARY_SUPPLEMENT

L-arginine, 2 g, three times daily, for 12 weeks

Oral L-arginine

Placebo tablet DIETARY_SUPPLEMENT

Identical inert placebo, three times daily, for 12 weeks

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Massachusetts General Hospital: collaborator
• School of Medicine, University of Nottingham: collaborator
• Memorial University of Newfoundland: collaborator

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

Arginine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Guanghua Lei, MD, PhD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yilun Wang, MD, PhD

CONTACT

86-18692267896; yilun_wang@csu.edu.cn

Zhenglei Zhu, MD

CONTACT

86-13054173564; 184890740@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 26, 2023
• Study Start: March 20, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)