Efficacy of a Dietary Supplement (Aqualief®) in Xerostomic Patients (NCT03612414) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of a Dietary Supplement (Aqualief®) in Xerostomic Patients
Italy60 participantsStarted 2016-06-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of Aqualief on salivation
Timeframe: Change from baseline to 6 days of treatment