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Clinical Effect Study of Pregabalin in Relieving Burning Mouth Syndrome Pain: A randomized controlled trial

Clinical Effect Study of Pregabalin in Relieving Burning Mouth Syndrome Pain: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105797
Enrollment
Unknown
Registered
2025-07-10
Start date
2025-07-10
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Burning mouth syndrome

Interventions

A group:Group A: Pregabalin oral solution, Beijing Jiulong Pharmaceutical Co., Ltd, Approval No.: State Pharmaceutical License No. H20244981, Specification: 200 ml,total 4 g. Method of administration
? Maintenance: weeks 3-4, according to the tolerance of the gradual adjustment of the dosage, 7.5 ml (150 mg)/ (ii) Maintenance: 3-4 weeks, gradually adjust the dose according to tolerance, 7.5 ml (15
B group:Group B: Methylcobalamin Tablets, Jiangxi Qingfeng Pharmaceutical Company, Approval No.: State Drug License H20051440, Specification: 0.5mg/tablet. Administration method: take after meal, 1 ta

Sponsors

Affiliated Stomatological Hospital of Guilin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. International Classification of Headache, Third Edition (ICHD-3) BMS diagnostic criteria -Oral pain lasting more than 2 hours per day for more than 3 months. -Characterized by burning pain and limited to the superficial oral mucosa. -May be accompanied by numbness of the tongue, dryness of the mouth, dysgeusia, or other discomfort. -The burning sensation persists or increases in intensity during the day without interfering with eating, drinking or sleeping. -The oral mucosa is normal in appearance and the clinical examination of the oral mucosa, including sensory examination, is normal. -No local or systemic causes of burning pain in the oral mucosa, such as oral mucositis, oral candidiasis, lingual inflammation, desiccation syndrome, diabetes mellitus, anemia and cardiovascular disease, etc. 2. Inclusion criteria for BMS subjects -Meet the diagnostic criteria of BMS -Age >= 18 and = 3 months -Visual Analog Score (VAS) > 3 points Understand, agree to participate in the study and sign the informed consent form, and cooperate with the treatment and follow-up visits.

Exclusion criteria

Exclusion criteria: 1.Oral mucosa, dentition or periodontal tissues with detectable organic lesions with pain, such as ulcers, deep caries, periodontitis, etc. 2.History of orofacial neuralgia, such as trigeminal neuralgia, glossopharyngeal neuralgia, diabetic neuropathy, post-chemotherapy neuropathy. 3.History of head and neck radiotherapy with salivary gland disease or other oral mucosal diseases. 4.Diabetes mellitus, autoimmune disease, or serious heart, liver, kidney and blood system diseases. 5.Primary mental illness (including major depression, major personality disorder) or history of substance abuse (other than caffeine or nicotine) 6.Comorbidity with other chronic pain-related conditions (e.g., fibromyalgia, chronic headache, postherpetic neuralgia) 7.Comorbidity with other vitamin B12 deficiency-related disorders (e.g., pernicious anemia) 8.Treatment with central nervous system medications (e.g., anxiolytics, GABAergic system-related medications) within the last 1 month. 9.Treatment that may affect the central nervous system (e.g., transcranial magnetic stimulation, electrical stimulation, etc.) within the last 6 months. 10.History of allergy to GABAergic system-related medications (e.g., pregabalin, gabapentin, clonazepam). 11.Severe cognitive impairment or inability to cooperate with the evaluation. 12.Pregnant or gestating women.

Design outcomes

Primary

MeasureTime frame
visual analog scale;

Countries

China

Contacts

Public ContactJiang Xinxiang

Affiliated Stomatological Hospital of Guilin Medical University

409314127@qq.com+86 136 5773 8957

Outcome results

None listed

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