Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syn... | NCT05729529

Studies
Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

NCT05729529

Sponsor

University of Catania

Status

Unknown status

Last Update Posted

Feb 15, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Burning Mouth Syndrome

Interventions

Lipoid acid gel
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2020Actual

Primary Completion Date

May 25, 2023Estimated

Completion Date

May 30, 2023Estimated

First Submitted Date

Feb 6, 2023

First Submission Date that Met QC Criteria

Feb 6, 2023

First Posted Date

Feb 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2023

Last Update Posted Date

Feb 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome.

Recent studies suggest the existence of neurological factors as a possible cause of the disease.

Detailed Description

A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables.

60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with a follow-up of 2 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lipoic acid gel	Active Comparator	Patients were treated with a topic gel of lipoic acid	Other: Lipoid acid gel
Placebo	Placebo Comparator	Patients treated with a placebo gel control	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lipoid acid gel	Other	Topic lipoid acid gel used with topic oral gel used on tongue	Lipoic acid gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution of burning mouth	Evolution of burning mouth symptoms change through a questionnaire	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome

Exclusion Criteria:

clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gaetano Isola	Contact	0953785652		gaetano.isola@unict.it
Rosalia Leonardi	Contact			rleonardi@unict.it

Overall Officials

Name	Affiliation	Role
Gaetano Isola	Università degli Studi di Catania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Policlinico G. Rodolico	Recruiting	Catania		95124	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study protocol

Types

Not provided

Time Frame

1 year

Access Criteria

Pubmed

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002054	Burning Mouth Syndrome

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided