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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03612414
Other study ID # Prot.49 May 31st, 2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2016
Est. completion date December 15, 2017

Study information

Verified date July 2018
Source Università degli Studi dell'Insubria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 15, 2017
Est. primary completion date October 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Aqualief
Three tablets/day
Placebo
Three tablets/day

Locations

Country Name City State
Italy Università degli Studi dell'Insubria Varese

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of Aqualief on salivation Changes in saliva production is measured (ml) Change from baseline to 6 days of treatment
Secondary Safety of Aqualief Incidence of Treatment-Emergent Adverse Events Occurrence of Adverse Events over the 6 days of treatment
Secondary Effect of Aqualief on dry mouth symptoms Evaluate the effect of treatments dry mouth symptoms trough Dry Mouth Questionnaire (Thomson Questionnaire) Change from baseline to 6 days of treatment
Secondary Effect of Aqualief on the pH of saliva Changes of saliva pH is measured Change from baseline to 6 days of treatment
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