NCT03612414

Efficacy of a Dietary Supplement (Aqualief®) in Xerostomic Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Xerostomia Due to Hyposecretion of Salivary Gland
• pH
• Saliva
• Quality of Life

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Aqualief	Three tablets/day
DIETARY_SUPPLEMENT	Placebo	Three tablets/day

Timeline

• Start date: 2016-06-15
• Primary completion: 2017-10-31
• Completion: 2017-12-15
• First posted: 2018-08-02
• Last updated: 2018-08-02

Locations

1 site across 1 country: Italy