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

NCT03612414 | Completed

• 1 other identifier: Prot.49 May 31st, 2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

xerostomia; pH; Carnosine; karkadé; Aqualief; Mucoadhesive

Outcome Measures

Primary Outcomes (1)

• Effect of Aqualief on salivation

  Changes in saliva production is measured (ml)

  Change from baseline to 6 days of treatment

Secondary Outcomes (3)

• Safety of Aqualief

  Occurrence of Adverse Events over the 6 days of treatment

• Effect of Aqualief on dry mouth symptoms

  Change from baseline to 6 days of treatment

• Effect of Aqualief on the pH of saliva

  Change from baseline to 6 days of treatment

Study Arms (2)

Aqualief® tablets

EXPERIMENTAL

400 mg mucoadhesive tablets; three times per day just

Dietary Supplement: Aqualief

Placebo tablets

PLACEBO COMPARATOR

400 mg mucoadhesive placebo tablets, three times per day just

Dietary Supplement: Placebo

Interventions

Aqualief DIETARY_SUPPLEMENT

Three tablets/day

Aqualief® tablets

Placebo DIETARY_SUPPLEMENT

Three tablets/day

Placebo tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

Università degli Studi dell'Insubria

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Luca Levrini, Prfo. MD.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization code
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Surgery and Medicine, Dental Hygiene School, Research Centre Cranio Facial Disease and Medicine, University of Insubria, Varese Italy

Model Details: randomized, double-blind, placebo-controlled clinical study

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 2, 2018
• Study Start: June 15, 2016
• Primary Completion: October 31, 2017
• Study Completion: December 15, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

IT (1)