Effect of the Dietary Supplement to Alleviate Dry Mouth.
ConditionXerostomia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLacer S.A.
About this trial
The goal of this study is to learn if dietary supplement works to improve dry mouth in adults. The main question it aims to answer is:
• Does dietary supplement reduce dry mouth sensation in subjects with dry mouth?
Participants will:
* Take dietary supplement every day for 7 days * Visit the pharmacy at the beginning and the end of the study
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Presence of subjective xerostomia.
Score ≥4 on the Numerical Rating Scale for Dryness (NRS, 0-10), established as the cut-off point for clinically relevant xerostomia.
Result consistent with xerostomia on the Fox Questionnaire.
Disqualifiers
Inability to understand or complete the study questionnaires.
Recent initiation of a specific treatment for xerostomia that may interfere with the evaluation.
Presence of clinical conditions that, in the investigator's judgment, may interfere with the assessment of the study outcomes.
Trial design
Design model
Single group
Treatments tested in this trial
Dietary Supplement
Dietary supplementDietary supplement will be taken daily for 7 days
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Dietary supplementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the dry mouth intensity at 7 days
The dry mouth sensation will be evaluated by numeric dryness scale from 0 (no dryness) to 10 (maximum dryness imaginable).
Time frame
From enrollment to the end of the study at 7 days Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: