Effect of the Ansileve Supplement on the Well-being of Parents of Children Who Have Experienced a Medical Emergency: A Randomized Controlled Study (ParentSOS)

September 15, 2026 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Effetto Dell'Integratore Ansileve Sul Funzionamento Genitoriale in Soggetti Esposti a un Evento Emergenziale Per il Bambino: Studio Randomizzato Controllato

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Known psychiatric disorders
  • Failure to provide written informed consent
  • Insufficient proficiency in the Italian language
  • Pregnancy or breastfeeding
  • Known allergy or intolerance to one or more components of the food supplement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1: Ansileve SOS Spray + Ansileve Capsules
Dietary supplement: Ansileve SOS Spray
Dietary 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.
Dietary supplement: Ansileve
Dietary 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.
Other: Arm 2: Ansileve SOS Spray + Placebo Capsules
Dietary supplement: Ansileve SOS Spray
Dietary 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.
Other: Arm 3: Placebo Spray + Ansileve Capsules
Dietary supplement: Ansileve
Dietary 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.
No Intervention: Arm 4: Placebo Spray + Placebo Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of the spray treatment (Ansileve SOS Spray vs placebo spray) on maternal functioning.
Time Frame: From baseline (T0) to 30 minutes after spray administration (T1).
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.
From baseline (T0) to 30 minutes after spray administration (T1).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term change in emotional impact and anxiety symptoms after Ansileve SOS Spray in parents.
Time Frame: From baseline (T0) to 30 minutes after spray administration (T1).
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).
From baseline (T0) to 30 minutes after spray administration (T1).
Long-Term Effects of Ansileve Capsules on Anxiety Symptoms in Parents.
Time Frame: From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).
Comparison of changes in GAD-7 anxiety scores after capsule administration between the Ansileve capsule group and the placebo capsule group.
From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).
Combined effects of Ansileve SOS Spray and Ansileve capsules on anxiety symptoms in parents
Time Frame: From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).
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.
From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborators

University of Milan
University of Calabria
Fondazione De Marchi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 15, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ParentSOS
  • 7192_15.07.2026_P_bis (Other Identifier: Comitato Etico Territoriale Lombardia 3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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