CaffeineNCT06195137
Caffeine vs. ALA in BMS Treatment. (BMS: Burning Mouth Syndrome. ALA: Alpha-Lipoic Acid.)
A study testing Caffeine and Alpha Lipoic Acid in people with Caffeine and Burning Mouth Syndrome, run by Lu Jiang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Caffeine, Burning Mouth Syndrome
- What is being tested?
- Caffeine and Alpha Lipoic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2021to 23 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Condition not better accounted for by another ICHD-3 diagnosis
Who cannot join
- Secondary BMS due to local or systemic disorders
- Prior treatment for BMS
- Psychiatric or progressive neurological disorders
- Systemic disorders potentially associated with oral disease
- Long-term history of smoking, drinking, or medication use
- Consumption of caffeinated products
Show all 10Show fewer
- Poor oral hygiene
- Abnormal blood test results (including blood count, glucose, serum iron, ferritin and transferrin, folic acid, or vitamin B12 levels)
- Incomplete medical records
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital of Stomatology, Sichuan University
Chengdu, 610041
About this study
Official title: Efficacy of Caffeine vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment
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.
Read the 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
- Being tested
- Caffeine, Alpha Lipoic Acid
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDietary supplement
caffeine supplementation
Alpha Lipoic AcidDrug
Also called ALA
600-800 mg ALA
| Study group | Role | What they receive |
|---|---|---|
| Caffeine group | 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. Receives: Dietary Supplement: Caffeine |
| Alpha Lipoic Acid (ALA) group | 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. Receives: Drug: Alpha Lipoic Acid |
| Control gruop | No intervention | Without intervention treatment, we provided BMS patients in Control group with disease explanation and psychological counseling for patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
During the interview or telephone follow-up with the patient, ask the patient to fill in the VAS rating scale.
Measured: Baseline and 2 weeks after intervention or observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start13 Dec 2021
- Primary completion15 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lu Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Jiang, Sichuan University
- Investigators
- Lu Jiang, Study director, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195137
- Sponsor's protocol ID
- WCHSIRB-D-2021-407
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu C, Yuan P, Qiu X, Liu D, Xu Y, Xiao Y, Zhou S, Zhang Z, Cai S, Ding W, Xu X, Hou F, Jiang L. Short-Term Dietary Caffeine Intake for Alleviating Symptoms of Burning Mouth Syndrome: A Randomised Controlled Comparison With Alpha-Lipoic Acid. J Oral Rehabil. 2025 Jul;52(7):969-978. doi: 10.1111/joor.13957. Epub 2025 Mar 14.
PubMed 40084800
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Caffeine vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment
- ClinicalTrials.gov ID
- NCT06195137
- Acronym / sponsor ID
- WCHSIRB-D-2021-407
- Conditions
- Caffeine, Burning Mouth Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Lu JiangUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caffeine group | Experimental | Dietary Supplement: CaffeineBurning 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. |
| Alpha Lipoic Acid (ALA) group | Active comparator | Drug: Alpha Lipoic AcidBurning 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. |
| Control gruop | No intervention | –Without intervention treatment, we provided BMS patients in Control group with disease explanation and psychological counseling for patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Condition not better accounted for by another ICHD-3 diagnosis
Key exclusion criteria (10 listed)
- Secondary BMS due to local or systemic disorders
- Prior treatment for BMS
- Psychiatric or progressive neurological disorders
- Systemic disorders potentially associated with oral disease
- Long-term history of smoking, drinking, or medication use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeinecaffeine supplementation | Dietary supplement | Caffeine group |
| Alpha Lipoic AcidAlso: ALA600-800 mg ALA | Drug | Alpha Lipoic Acid (ALA) group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Baseline and 2 weeks after intervention or observation
During the interview or telephone follow-up with the patient, ask the patient to fill in the VAS rating scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Derived from this study: PubMed 40084800Wu C, Yuan P, Qiu X, Liu D, Xu Y, Xiao Y, Zhou S, Zhang Z, Cai S, Ding W, Xu X, Hou F, Jiang L. Short-Term Dietary Caffeine Intake for Alleviating Symptoms of Burning Mouth Syndrome: A Randomised Controlled Comparison With Alpha-Lipoic Acid. J Oral Rehabil. 2025 Jul;52(7):969-978. doi: 10.1111/joor.13957. Epub 2025 Mar 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Jiang study director
Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine and Alpha Lipoic Acid in people with Caffeine and Burning Mouth Syndrome, run by Lu Jiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Baseline and 2 weeks after intervention or observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06195137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.