Efficacy of a Dietary Supplement (Aqualief®) in Xerostomic Patients (Aqualief)
Primary Purpose
Xerostomia Due to Hyposecretion of Salivary Gland, pH, Saliva
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Aqualief
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Xerostomia Due to Hyposecretion of Salivary Gland focused on measuring xerostomia, pH, Carnosine, karkadé, Aqualief, Mucoadhesive
Eligibility Criteria
Inclusion Criteria:
- Subjects of both sex
- Age ≥ a 18 years
- Able to understand and sign the Informed Consent, and fill in the patient's diary
- Subjects suffering from Xerosotmia Grade 1-2 (according to RTOG/EORTC scale)
- Sjögren Sindrome
- Lambert-Eaton Sindrome
- Diabetes mellitus and low metabolic control
- Anxiety
- Alcool abuse
- Salivary glands trauma
- Radio and Chemotherapy for head & neck cancer
- Methamphetamine, cannabis, heroin abuse
- Xerostomia caused by (single and concomitant, i.e. Anti-depressive and anxyolitic drugs; Antihistaminic drugs; Decongestive drugs; Antihypertensive drugs; Muscle relaxants; Urinary incontinence drugs; Drugs for Parkinson treatment)
- Subjects affected by paradental pathology diagnosed according to AAOP criteria, PSR 2-3
Exclusion Criteria:
- Contraindication and/or Hypersensitivity to product's components, and in particular carnosine and Hibiscus
- Subjects that are under treatment with products or drugs ( ie pilocarpin) for hypofunctionality of salivary glands
- Subjects with total ablation of salivary glands caused by chemo or radiotherapy
- Use of experimental drugs during 30 days before the enrolment or during the study
- Conditions that can interfere with the study
- Xerostomia grade 3 or higher
Sites / Locations
- Università degli Studi dell'Insubria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aqualief® tablets
Placebo tablets
Arm Description
400 mg mucoadhesive tablets; three times per day just
400 mg mucoadhesive placebo tablets, three times per day just
Outcomes
Primary Outcome Measures
Effect of Aqualief on salivation
Changes in saliva production is measured (ml)
Secondary Outcome Measures
Safety of Aqualief
Incidence of Treatment-Emergent Adverse Events
Effect of Aqualief on dry mouth symptoms
Evaluate the effect of treatments dry mouth symptoms trough Dry Mouth Questionnaire (Thomson Questionnaire)
Effect of Aqualief on the pH of saliva
Changes of saliva pH is measured
Full Information
NCT ID
NCT03612414
First Posted
July 4, 2018
Last Updated
July 26, 2018
Sponsor
Università degli Studi dell'Insubria
1. Study Identification
Unique Protocol Identification Number
NCT03612414
Brief Title
Efficacy of a Dietary Supplement (Aqualief®) in Xerostomic Patients
Acronym
Aqualief
Official Title
Effetti Sulla Salivazione a Seguito Della Somministrazione di un Integratore Alimentare (Aqualief®) a Base di Carnosina ed Hibiscus Nei Soggetti Xerostomici: Studio Multicentrico, Randomizzato, in Doppio Cieco, Controllato Verso Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 15, 2016 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi dell'Insubria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Xerostomia is defined as the subjective complaint of dry mouth. Symptoms of dry mouth may range from mild oral discomfort to significant oral disease that can compromise patients' health, dietary intake and quality of life. Xerostomia is accompanied by numerous signs and symptoms mainly in the mucous membranes, lips, tongue, salivary glands and teeth.
This study was designed to verify efficacy and safety of a novel dietary supplement (Aqualief),designed with the aim of stabilizing the saliva flux and pH at a neutral level and to improve the acid buffering capacity of saliva.
Detailed Description
Sixty patients with xerostomia (grade 1-2 according to RTOG/EORTC) from different etiologies were recruited at the Clinica Odontoiatrica dell'Università degli studi dell'Insubria (Varese, Italy). Exclusion criteria were subjects under treatment using drugs to treat hyposalivation (e.g. pilocarpine) and xerostomia grade ≥ 3. Patients with severe hyposalivation were excluded (saliva flow rate at baseline <0.1 ml min-1) due to their inability to dissolve the tablet formulation.
Written informed consent was received from all patients before study initiation. The study was conducted in accordance with the principles laid out by the Declaration of Helsinki 1964 and its subsequent amendments and with the International Committee on Harmonization Guidelines for Good Clinical Practice and in compliance with local ethical and legal requirements. The study was approved by the ethics committee at the participating site.
The study was a prospective, randomized, double-blind, placebo-controlled trial undertaken at the Clinica Odontoiatrica dell'Università degli Studi dell'Insubria (Varese, Italy). Eligible patients who had developed xerostomia RTOG/EORTC grade 1-2 were randomized in a 1:1 ratio, with one group receiving three Aqualief tablets (after meals: breakfast, lunch, dinner) daily for 6 days. The second group received a placebo tablet given with the same regimen. The primary objective of the study was to assess the safety and efficacy of Aqualief in stabilizing the saliva pH at a neutral level compared with placebo. The secondary objective was to determine whether Aqualief induced an increase of unstimulated or stimulated saliva and in ameliorating the symptoms related to oral dryness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia Due to Hyposecretion of Salivary Gland, pH, Saliva, Quality of Life
Keywords
xerostomia, pH, Carnosine, karkadé, Aqualief, Mucoadhesive
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled clinical study
Masking
ParticipantCare ProviderInvestigator
Masking Description
Randomization code
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aqualief® tablets
Arm Type
Experimental
Arm Description
400 mg mucoadhesive tablets; three times per day just
Arm Title
Placebo tablets
Arm Type
Placebo Comparator
Arm Description
400 mg mucoadhesive placebo tablets, three times per day just
Intervention Type
Dietary Supplement
Intervention Name(s)
Aqualief
Intervention Description
Three tablets/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Three tablets/day
Primary Outcome Measure Information:
Title
Effect of Aqualief on salivation
Description
Changes in saliva production is measured (ml)
Time Frame
Change from baseline to 6 days of treatment
Secondary Outcome Measure Information:
Title
Safety of Aqualief
Description
Incidence of Treatment-Emergent Adverse Events
Time Frame
Occurrence of Adverse Events over the 6 days of treatment
Title
Effect of Aqualief on dry mouth symptoms
Description
Evaluate the effect of treatments dry mouth symptoms trough Dry Mouth Questionnaire (Thomson Questionnaire)
Time Frame
Change from baseline to 6 days of treatment
Title
Effect of Aqualief on the pH of saliva
Description
Changes of saliva pH is measured
Time Frame
Change from baseline to 6 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects of both sex
Age ≥ a 18 years
Able to understand and sign the Informed Consent, and fill in the patient's diary
Subjects suffering from Xerosotmia Grade 1-2 (according to RTOG/EORTC scale)
Sjögren Sindrome
Lambert-Eaton Sindrome
Diabetes mellitus and low metabolic control
Anxiety
Alcool abuse
Salivary glands trauma
Radio and Chemotherapy for head & neck cancer
Methamphetamine, cannabis, heroin abuse
Xerostomia caused by (single and concomitant, i.e. Anti-depressive and anxyolitic drugs; Antihistaminic drugs; Decongestive drugs; Antihypertensive drugs; Muscle relaxants; Urinary incontinence drugs; Drugs for Parkinson treatment)
Subjects affected by paradental pathology diagnosed according to AAOP criteria, PSR 2-3
Exclusion Criteria:
Contraindication and/or Hypersensitivity to product's components, and in particular carnosine and Hibiscus
Subjects that are under treatment with products or drugs ( ie pilocarpin) for hypofunctionality of salivary glands
Subjects with total ablation of salivary glands caused by chemo or radiotherapy
Use of experimental drugs during 30 days before the enrolment or during the study
Conditions that can interfere with the study
Xerostomia grade 3 or higher
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Levrini, Prfo. MD.
Organizational Affiliation
Università degli Studi dell'Insubria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università degli Studi dell'Insubria
City
Varese
ZIP/Postal Code
21100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a Dietary Supplement (Aqualief®) in Xerostomic Patients
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