Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Caffeine

+ Alpha Lipoic Acid

Dietary SupplementDrug
Who is being recruted

Burning Mouth Syndrome

+ Stomatognathic Diseases

+ Mouth Diseases

From 18 to 75 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2021
See protocol details

Summary

Principal SponsorLu Jiang
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 13, 2021

Actual date on which the first participant was enrolled.

Burning Mouth Syndrome (BMS) is a challenging condition that causes a burning sensation in the mouth without an obvious cause. It is believed to involve nerve issues, hormonal imbalances, and psychological factors. This study aims to determine whether caffeine or alpha-lipoic acid is more effective in treating BMS. Caffeine is known for its ability to stimulate the central nervous system, enhance mood, and reduce pain. This research is important because it may help identify a better treatment option for those suffering from the discomfort of BMS, potentially improving their quality of life. Participants in this study are given either caffeine or alpha-lipoic acid to evaluate their effects on BMS symptoms. The treatments are administered to observe changes in pain levels and other symptoms associated with BMS. The study carefully monitors these effects to understand which substance provides better relief. While caffeine may improve mood and cognitive function due to its stimulating properties, both substances are being evaluated for their potential benefits in managing the burning sensations and discomfort associated with the syndrome.

Official TitleEfficacy of Caffeine vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment
NCT06195137
Principal SponsorLu Jiang
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Burning Mouth SyndromeStomatognathic DiseasesMouth Diseases

Criteria

5 inclusion criteria required to participate
Adults over 18 years of age

Diagnosis of BMS according to the 3rd edition of the International Classification of Headache Disorders (ICHD-3)

Daily intraoral burning or dysaesthesia lasting for more than 2 hours for over 3 months

Normal oral mucosa and sensory testing

Show More Criteria

10 exclusion criteria prevent from participating
Secondary BMS due to local or systemic disorders

Prior treatment for BMS

Psychiatric or progressive neurological disorders

Systemic disorders potentially associated with oral disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Burning mouth syndrome (BMS) patients in Caffeine group were provided with BMS disease explanation and psychological counseling. Then they were told to drink instant coffee containing 120-150 mg of the active ingredient caffeine (2 bags of Nescafe Black Coffee, 1.8g each) at a certain point in time from 8:00 to 12:00 every day, for 2 consecutive weeks.

Group II

Active Comparator
Burning mouth syndrome (BMS) patients in the ALA group were provided with BMS disease explanation and psychological counseling. Then they took α-lipoic acid (ALA) 3 times a day, after meals, 200 mg each time, for 2 consecutive weeks.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

West China Hospital of Stomatology, Sichuan University

Chengdu, ChinaOpen West China Hospital of Stomatology, Sichuan University in Google Maps
CompletedOne Study Center