NCT06195137

Caffeine vs. ALA in BMS Treatment. (BMS: Burning Mouth Syndrome. ALA: Alpha-Lipoic Acid.)

Efficacy of Caffeine vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Lu Jiang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the efficacy of caffeine and alpha-lipoic acid in the treatment of burning mouth syndrome by symptom assessment with visual analogue scale.

Detailed description

The etiology of BMS is multifactorial, involving a complex interplay of neuropathic, psychological, neuroendocrine, and immunological factors. Neurologically, BMS has been categorized into three subtypes: peripheral small fiber neuropathy, subclinical trigeminal neuropathy, and inhibitory dopaminergic deficiency. Neuroimaging and peripheral nerve studies have further implicated altered brain activation patterns and increased expression of specific receptors like TRPV1 and P2X3 in the pathogenesis of BMS. Hormonal imbalances, particularly in estrogen levels, have also been suggested to contribute to contribute to the condition. Caffeine, a xanthine alkaloid chemically known as 1,3,7-trimethylxanthine, is recognized for its diverse biological functions. As a central nervous system stimulant, its primary mechanism involves antagonizing adenosine receptors, thereby enhancing the release of neurotransmitters such as dopamine and norepinephrine, which are known to play roles in analgesic pathways. Caffeine is also noted for its neuroprotective properties and is theorized to reduce the risk of neurodegenerative diseases. It affects the central processing of pain and is involved in regulating circadian rhythms and sleep-wake cycles. Additionally, caffeine has mild anti-inflammatory properties. Its stimulatory effects may also improve mood and cognitive function.

Conditions

• Caffeine
• Burning Mouth Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Caffeine	caffeine supplementation
DRUG	Alpha Lipoic Acid	600-800 mg ALA

Timeline

• Start date: 2021-12-13
• Primary completion: 2023-06-15
• Completion: 2023-06-23
• First posted: 2024-01-08
• Last updated: 2024-01-08

Locations

1 site across 1 country: China