The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether the dietary supplement Ansileve (Ansileve SOS spray and Ansileve capsules) can improve psychological well-being and parental functioning in mothers and fathers of children experiencing an acute medical event requiring hospital care.
The main questions are:
1. Does acute administration of Ansileve SOS spray improve maternal functioning in the short term, as measured by the Barkin Index of Maternal Functioning (BIMF), compared with placebo? 2. Does Ansileve SOS spray and the subsequent 30-day supplementation with Ansileve capsules reduce anxiety symptoms and improve emotional well-being in parents, compared with placebo?
Researchers will compare participants receiving Ansileve SOS spray and/or Ansileve capsules with participants receiving matching placebo products to determine whether the intervention improves parental functioning, reduces anxiety symptoms, and supports psychological recovery after a stressful event involving their child.
Participants will:
* Be mothers and fathers (≥18 years) of children admitted for an acute medical event at the Pediatria Immunoreumatologia Unit of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico * Complete validated questionnaires assessing functioning (BIMF, only mothers), emotional impact of the event \[Impact of Event Scale - Revised (IES-R)\], and anxiety symptoms \[Generalized Anxiety Disorder Scale (GAD-7)\] at baseline and during follow-up * Receive either Ansileve SOS spray or placebo spray at study enrolment. * Take either Ansileve capsules or placebo capsules daily for 30 days according to the assigned treatment group * Complete a follow-up assessment to evaluate treatment adherence and possible adverse events.
Mothers and fathers of children presenting to the Pediatria Immunoreumatologia Unit of the De Marchi Pediatric Clinic for an acute medical event
Age ≥18 years
Provision of written informed consent
Known psychiatric disorders
Failure to provide written informed consent
Insufficient proficiency in the Italian language
Pregnancy or breastfeeding
Factorial
Ansileve SOS Spray
Dietary supplementDietary supplement in spray containing Ashwagandha, Hawthorn, Hemp seed oil, and Lavender, known to promote relaxation and support emotional balance. It will be administered as 4 sprays under the tongue, three times daily.
Ansileve
Dietary supplementDietary supplement in capsule form combining plant extracts of Melissa officinalis and Griffonia simplicifolia, B-group vitamins, and hydrolyzed marine peptides. Two capsules will be administered daily, away from meals.
Effect of the spray treatment (Ansileve SOS Spray vs placebo spray) on maternal functioning.
Change in maternal functioning after spray administration, measured by the change in BIMF questionnaire score, comparing the Ansileve SOS Spray group with the placebo spray group.
Short-term change in emotional impact and anxiety symptoms after Ansileve SOS Spray in parents.
Comparison of changes in scores for the emotional impact of the traumatic event and anxiety symptoms between Ansileve SOS Spray and placebo groups, measured using validated questionnaires (IES-R and GAD-7).
Long-Term Effects of Ansileve Capsules on Anxiety Symptoms in Parents.
Comparison of changes in GAD-7 anxiety scores after capsule administration between the Ansileve capsule group and the placebo capsule group.
Combined effects of Ansileve SOS Spray and Ansileve capsules on anxiety symptoms in parents
Evaluation of the combined effect of Ansileve SOS Spray and Ansileve capsules on anxiety symptoms by comparing changes in GAD-7 scores between the active combination group and the placebo group.
Click on the lead sponsor to view all of their trials.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead sponsor
University of Milan
Collaborator
Fondazione De Marchi
Collaborator
University of Calabria
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
