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

NCT07828548 | Not Yet Recruiting

• 2 other identifiers: ParentSOS7192_15.07.2026_P_bis
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• 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.

Conditions

Parenting Anxiety; Psychological Well-being; Child Hospitalization

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline (T0) to 30 minutes after spray administration (T1).

Secondary Outcomes (3)

• Short-term change in emotional impact and anxiety symptoms after Ansileve SOS Spray in parents.

  From baseline (T0) to 30 minutes after spray administration (T1).

• Long-Term Effects of Ansileve Capsules on Anxiety Symptoms in Parents.

  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

  From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).

Study Arms (4)

Arm 1: Ansileve SOS Spray + Ansileve Capsules

ACTIVE COMPARATOR

Dietary Supplement: Ansileve SOS Spray; Dietary Supplement: Ansileve

Arm 2: Ansileve SOS Spray + Placebo Capsules

OTHER

Dietary Supplement: Ansileve SOS Spray

Arm 3: Placebo Spray + Ansileve Capsules

OTHER

Dietary Supplement: Ansileve

Arm 4: Placebo Spray + Placebo Capsules

NO INTERVENTION

Interventions

Ansileve SOS Spray DIETARY_SUPPLEMENT

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.

Arm 1: Ansileve SOS Spray + Ansileve Capsules; Arm 2: Ansileve SOS Spray + Placebo Capsules

Ansileve DIETARY_SUPPLEMENT

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.

Arm 1: Ansileve SOS Spray + Ansileve Capsules; Arm 3: Placebo Spray + Ansileve Capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: collaborator
• Fondazione De Marchi: collaborator
• University of Calabria: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Cristiana Berti

CONTACT

+39 02 55034338; cristiana.berti@policlinico.mi.it

Silvia Bettocchi

CONTACT

silvia.bettocchi.nutrizione@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share