Xerostomia Due to Hyposecretion of Salivary GlandAqualiefNCT03612414
Efficacy of a Dietary Supplement (Aqualief®) in Xerostomic Patients
A study testing Aqualief in people with Xerostomia Due to Hyposecretion of Salivary Gland and pH, run by Università degli Studi dell'Insubria at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia Due to Hyposecretion of Salivary Gland, pH, Saliva
- What is being tested?
- Aqualief
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2016to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Aqualief, Placebo
- Keywords
- xerostomia, pH, Carnosine, karkadé, Aqualief, Mucoadhesive
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AqualiefDietary supplement
Three tablets/day
PlaceboDietary supplement
Three tablets/day
| Study group | Role | What they receive |
|---|---|---|
| Aqualief® tablets | Experimental | 400 mg mucoadhesive tablets; three times per day just Receives: Dietary Supplement: Aqualief |
| Placebo tablets | Placebo comparator | 400 mg mucoadhesive placebo tablets, three times per day just Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Aqualief on salivation
Changes in saliva production is measured (ml)
Measured: Change from baseline to 6 days of treatment
Secondary outcomes (3)
Safety of Aqualief
Incidence of Treatment-Emergent Adverse Events
Measured: Occurrence of Adverse Events over the 6 days of treatment
Effect of Aqualief on dry mouth symptoms
Evaluate the effect of treatments dry mouth symptoms trough Dry Mouth Questionnaire (Thomson Questionnaire)
Measured: Change from baseline to 6 days of treatment
Effect of Aqualief on the pH of saliva
Changes of saliva pH is measured
Measured: Change from baseline to 6 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start15 Jun 2016
- Primary completion31 Oct 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerostomia Due to Hyposecretion of Salivary GlandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Luca Levrini, Università degli Studi dell'Insubria
- Investigators
- Luca Levrini, Prfo. MD., Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612414
- Sponsor's protocol ID
- Prot.49 May 31st, 2016
- Acronym
- Aqualief
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03612414
- Acronym / sponsor ID
- Aqualief / Prot.49 May 31st, 2016
- Keywords
- xerostomia, pH, Carnosine, karkadé, Aqualief, Mucoadhesive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Aqualief® tablets | Experimental | Dietary Supplement: Aqualief400 mg mucoadhesive tablets; three times per day just |
| Placebo tablets | Placebo comparator | Dietary Supplement: Placebo400 mg mucoadhesive placebo tablets, three times per day just |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AqualiefThree tablets/day | Dietary supplement | Aqualief® tablets |
| PlaceboThree tablets/day | Dietary supplement | Placebo tablets |
Primary outcome
Effect of Aqualief on salivation
Time frame: Change from baseline to 6 days of treatment
Changes in saliva production is measured (ml)
3 secondary outcomes
Safety of Aqualief
Time frame: Occurrence of Adverse Events over the 6 days of treatment
Effect of Aqualief on dry mouth symptoms
Time frame: Change from baseline to 6 days of treatment
Effect of Aqualief on the pH of saliva
Time frame: Change from baseline to 6 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
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RecruitingObservational study
Screening of Biomarkers and Related Mechanisms for RIX
Xerostomia Due to Radiotherapy (Disorder)
Active, not recruitingPhase 3
Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine
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Enrolling by invitationPhase 1/2
Hyaluronic Acid in the Treatment of Hyposalivation
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Not yet recruitingPhase 2
Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Levrini, Prfo. MD. principal investigator
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqualief in people with Xerostomia Due to Hyposecretion of Salivary Gland and pH, run by Università degli Studi dell'Insubria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Aqualief on salivation (time frame: Change from baseline to 6 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.