Quality of Life Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT06238557 -
Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
|
||
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT05472935 -
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
|
N/A | |
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04281953 -
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
|
||
Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Active, not recruiting |
NCT05903638 -
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT03813420 -
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
|
N/A | |
Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Recruiting |
NCT05233020 -
Robotic Versus Hybrid Assisted Ventral Hernia Repair
|
N/A | |
Terminated |
NCT03304184 -
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
|
Phase 3 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A |