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Can a sleep supplement soothe aching knees? new trial tests melatonin for arthritis pain

NCT ID NCT06012175

Symptom relief Sponsor: Xiangya Hospital of Central South University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study tested whether taking melatonin (3 mg each night for 12 weeks) can safely reduce pain in people with knee osteoarthritis. Researchers enrolled 340 adults aged 40-80 with moderate knee pain. Half received melatonin and half received a placebo pill. The main goal was to measure changes in pain using a standard arthritis questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
melatonin (dietary supplement)
What this could lead to
If it works, melatonin could offer a simple, low-cost option to help manage knee osteoarthritis pain.
What could go wrong
This is a completed trial, but results are not yet reported. Melatonin is generally safe, but its effect on arthritis pain may be small or no better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

340 people

The number who actually took part.

Started

Nov 2023

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 cardiopulmonary diseases. 9. Uncontrolled hypertension or diabetes mellitus. 10. Diagnosis of malignant tumors. 11. Pregnant or contemplating pregnancy or breastfeeding. 12. Any use of melatonin supplement before enrollment within 30 days. 13. Allergic to melatonin or its preparation. 14. Any use of anti-depressive/psychotropic drugs.

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis, knee

Contacts and locations

Locations

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.