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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03612414
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Luca Levrini, Università degli Studi dell'Insubria

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.


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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aqualief® tablets
400 mg mucoadhesive tablets; three times per day just
Dietary Supplement: Aqualief
Three tablets/day

Placebo Comparator: Placebo tablets
400 mg mucoadhesive placebo tablets, three times per day just
Dietary Supplement: Placebo
Three tablets/day




Primary Outcome Measures :
  1. Effect of Aqualief on salivation [ Time Frame: Change from baseline to 6 days of treatment ]
    Changes in saliva production is measured (ml)


Secondary Outcome Measures :
  1. Safety of Aqualief [ Time Frame: Occurrence of Adverse Events over the 6 days of treatment ]
    Incidence of Treatment-Emergent Adverse Events

  2. 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)

  3. Effect of Aqualief on the pH of saliva [ Time Frame: Change from baseline to 6 days of treatment ]
    Changes of saliva pH is measured



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Italy
Università degli Studi dell'Insubria
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
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Principal Investigator: Luca Levrini, Prfo. MD. Università degli Studi dell'Insubria

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Responsible Party: Prof. Luca Levrini, Director of the Department of Surgery and Medicine, Dental Hygiene School, Research Centre Cranio Facial Disease and Medicine, University of Insubria, Varese Italy, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03612414     History of Changes
Other Study ID Numbers: Prot.49 May 31st, 2016
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Luca Levrini, Università degli Studi dell'Insubria:
xerostomia
pH
Carnosine
karkadé
Aqualief
Mucoadhesive
Additional relevant MeSH terms:
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Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases