Status:
COMPLETED
Melatonin for Knee Osteoarthritis Patients
Lead Sponsor:
Xiangya Hospital of Central South University
Collaborating Sponsors:
Peking University People's Hospital
West China Hospital
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
By recruiting knee osteoarthritis patients and treating them with melatonin, this study aims to determine the efficacy and safety of melatonin in alleviating pain in this patient population.
Detailed Description
Knee osteoarthritis (KOA) is a major source of pain and disability among adults worldwide, but the treatment options for patients with painful KOA are inadequate. The current first-line oral drugs hav...
Eligibility Criteria
Inclusion
- 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 and able to provide written informed consent.
Exclusion
- 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 cardiopulmonary diseases.
- Uncontrolled hypertension or diabetes mellitus.
- Diagnosis of malignant tumors.
- Pregnant or contemplating pregnancy or breastfeeding.
- Any use of melatonin supplement before enrollment within 30 days.
- Allergic to melatonin or its preparation.
- Any use of anti-depressive/psychotropic drugs.
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2025
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT06012175
Start Date
November 2 2023
End Date
September 24 2025
Last Update
November 20 2025
Active Locations (1)
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1
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000