Efficacy of a Dietary Supplement (Aqualief®) in Xerostomic Patients (Aqualief)
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|ClinicalTrials.gov Identifier: NCT03612414|
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Xerostomia Due to Hyposecretion of Salivary Gland pH Saliva Quality of Life||Dietary Supplement: Aqualief Dietary Supplement: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized, double-blind, placebo-controlled clinical study|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Randomization code|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||June 15, 2016|
|Actual Primary Completion Date :||October 31, 2017|
|Actual Study Completion Date :||December 15, 2017|
Experimental: Aqualief® tablets
400 mg mucoadhesive tablets; three times per day just
Dietary Supplement: Aqualief
Placebo Comparator: Placebo tablets
400 mg mucoadhesive placebo tablets, three times per day just
Dietary Supplement: Placebo
- Effect of Aqualief on salivation [ Time Frame: Change from baseline to 6 days of treatment ]Changes in saliva production is measured (ml)
- Safety of Aqualief [ Time Frame: Occurrence of Adverse Events over the 6 days of treatment ]Incidence of Treatment-Emergent Adverse Events
- Effect of Aqualief on dry mouth symptoms [ Time Frame: Change from baseline to 6 days of treatment ]Evaluate the effect of treatments dry mouth symptoms trough Dry Mouth Questionnaire (Thomson Questionnaire)
- Effect of Aqualief on the pH of saliva [ Time Frame: Change from baseline to 6 days of treatment ]Changes of saliva pH is measured
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612414
|Università degli Studi dell'Insubria|
|Varese, Italy, 21100|
|Principal Investigator:||Luca Levrini, Prfo. MD.||Università degli Studi dell'Insubria|