MedTrace Logo

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

NCT03612414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-02

No results posted yet for this study

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Aqualief

Three tablets/day

DIETARY_SUPPLEMENT

Placebo

Three tablets/day

Sponsors & Collaborators

  • Università degli Studi dell'Insubria

    lead OTHER

Principal Investigators

  • Luca Levrini, Prfo. MD. · Università degli Studi dell'Insubria

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-15
Primary Completion
2017-10-31
Completion
2017-12-15

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03612414 on ClinicalTrials.gov