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Melatonin Administration for Alleviating Clinical Symptoms of Burning Mouth Syndrome: An Open-Label, Randomised Controlled Trial

Melatonin Administration for Alleviating Clinical Symptoms of Burning Mouth Syndrome: An Open-Label, Randomised Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115337
Enrollment
Unknown
Registered
2025-12-24
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning mouth syndrome

Interventions

Melatonin + alpha-lipoic acid (ALA) group:Take alpha-lipoic acid (ALA), which is currently commonly used to treat BMS, three times a day, 200mg each time, for four consecutive weeks. And take melaton
Alpha-lipoic acid (ALA) group:Take alpha-lipoic acid (ALA), which is currently commonly used to treat BMS, three times a day, 200mg each time, for four consecutive weeks.

Sponsors

West China School/Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The inclusion criteria for participants in this experiment are as follows: Patients over 18 years old who meet the diagnostic criteria for BMS in the 3rd edition of the International Classification of Headache Diseases (ICHD-3) (International Headache Classification Committee, 2013); Chronic oral and facial pain recurs daily, accompanied by a burning sensation or discomfort on the surface of the oral mucosa, lasting for more than 2 hours per day for more than 3 months. The appearance of the oral mucosa is normal clinical examinations, including sensory tests, were normal. Another ICHD-3 diagnosis does not better explain the condition.

Exclusion criteria

Exclusion criteria: 1. Secondary BMS caused by local (candidiasis, lichen planus, etc.) or systemic diseases (hypothyroidism, diabetes, etc.); 2.Currently taking anti-anxiety drugs to induce sleep, antidepressants, anticonvulsants or psychotropic drugs; 3. There has been a history of exogenous melatonin use within the past 3 months; 4. Oral cavity patients with poor hygiene; 5.Patients with abnormal blood test results (including blood cell count, glucose, serum iron, ferritin and transferrin, folic acid or vitamin B12 levels); 6.Have been or are currently undergoing plant-based therapy or dietary supplement treatment containing melatonin, serotonin and tryptophan; 7. Working at night, traveling or on business across time zones; 8. Currently receiving anticoagulant drug treatment; 9.Patients with incomplete personal medical records; 10.Patients who are unwilling to participate in the study; 11. Patients who cannot adhere to completing the research requirements.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale Scores;

Countries

China

Contacts

Public ContactJiang Lu

West China School/Hospital of Stomatology, Sichuan University

jianglu@scu.edu.cn+86 159 2851 9595

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026