Melatonin for Knee Osteoarthritis Patients

NCT06012175 | Completed

• 1 other identifier: 20230731
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Melatonin; Pain

Outcome Measures

Primary Outcomes (1)

• 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 (17)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score.

  Baseline, Weeks 2, 4, 6, 8 and 10

• Knee pain on a visual analogue scale (VAS).

  Baseline, Weeks 2, 4, 6, 8, 10, and 12

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score.

  Baseline, Weeks 2, 4, 6, 8, 10 and 12

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score.

  Baseline, Weeks 2, 4, 6, 8, 10 and 12

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score.

  Baseline, Weeks 2, 4, 6, 8, 10 and 12

Other Outcomes (5)

• Short Physical Performance Battery (SPPB) scores.

  Baseline, Weeks 4, 8, and 12

• Grip strength.

  Baseline, Week 4, 8, and 12

• Bone mineral density (BMD).

  Baseline, Week 12

Study Arms (2)

Oral melatonin supplementation

EXPERIMENTAL

Participants in the intervention arm will receive one 3 mg melatonin tablet every night before going to bed

Dietary Supplement: Melatonin

Placebo

PLACEBO COMPARATOR

The control group will receive an identical-looking inert placebo tablet every night before going to bed

Dietary Supplement: Placebo

Interventions

Melatonin DIETARY_SUPPLEMENT

One 3 mg melatonin tablet every night before bedtime for 12 weeks

Oral melatonin supplementation

Placebo DIETARY_SUPPLEMENT

One placebo tablet, having an identical appearance to the melatonin tablet, every night before bedtime 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 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 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Peking University People's Hospital: collaborator
• West China Hospital: collaborator
• Massachusetts General Hospital: collaborator
• School of Medicine, University of Nottingham: collaborator

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

Melatonin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Chao Zeng, MD, PhD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

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: August 8, 2023
• First Posted: August 25, 2023
• Study Start: November 2, 2023
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)